Development of Standardized Extubation Guidelines in a Medical Intensive Care Unit

Oral endotracheal tube (OETT) intubation is a medical intervention for critically ill medical patients who have lost the ability to maintain their airway, suffer respiratory failure, or have deteriorated clinically to the point at which loss of the ability to protect their airway is imminent. For these patients, intubation and mechanical ventilation (MV) is appropriate. Self-extubation (SE) is an event in which an intubated patient receiving mechanical ventilation removes the endotracheal tube before removal is deemed clinically appropriate. Self-extubation disrupts medical treatment and may lead to emergent re-intubation. The Intensive Care Unit (ICU) studied is a 25-bed unit for critically ill medical patients at an academic hospital in urban Utah. The unit recently expanded from 17 to 25 beds. This expansion opened February 2017, and new nursing staff are being trained to accommodate the change. The goal of the unit was 10 or fewer SE events for the previous fiscal year; 17 events occurred. Analyzing incident report data showed that 70% of the patients who self-extubated during the period July 2015-March 2017 did not require reintubation. No standardized process had previously existed for evaluating appropriate patients for extubation. This unit is also designated for teaching medical housestaff. This entails monthly rotations of pulmonary/critical care fellows, residents, interns, and medical students. The objectives for this project were to: 1. create a clinical guideline to promote timely controlled planned extubation; 2. present the guideline to medical directors and nursing administration for possible implementation on the unit; 3. provide education on readiness for controlled extubation to nursing staff; 4. disseminate project findings through presentation at the Snowbird Continuing Medical Education (CME) conference. Relevant topics evaluated in the literature review include timely extubation criteria and recommendations, ventilator weaning parameters, sedation types and methods, and problems with prolonged mechanical ventilation. Implementation of project goals included designing the guideline using incident report data, performing root cause analysis for the events, and using information from the literature review along with feedback from the content experts and project chair. Education for unit nursing staff is also a critical component. The guideline was presented at staff meeting in April. In summary, SE is a disruptive event in which a patient removes his or her OETT prematurely before clinicians have deemed it appropriate to discontinue MV therapy. Although it is disruptive, the majority of patients do not require reintubation. This suggests that a timely extubation guideline of objective clinical criteria is appropriate and needed for an expanding medical critical care unit.

Running head: STANDARDIZED EXTUBATION GUIDELINES . Development of Standardized Extubation Guidelines in a Medical Intensive Care Unit Ben Bradford, BS, BSN, RN, CCRN, DNP-Student The University of Utah In partial fulfillment of the requirements for the Doctor of Nursing Practice STANDARDIZED EXTUBATION GUIDELINES Executive Summary 2 Oral endotracheal tube (OETT) intubation is a medical intervention for critically ill medical patients who have lost the ability to maintain their airway, suffer respiratory failure, or have deteriorated clinically to the point at which loss of the ability to protect their airway is imminent. For these patients, intubation and mechanical ventilation (MV) is appropriate. Self-extubation (SE) is an event in which an intubated patient receiving mechanical ventilation removes the endotracheal tube before removal is deemed clinically appropriate. Self-extubation disrupts medical treatment and may lead to emergent reintubation. The Intensive Care Unit (ICU) studied is a 25-bed unit for critically ill medical patients at an academic hospital in urban Utah. The unit recently expanded from 17 to 25 beds. This expansion opened February 2017, and new nursing staff are being trained to accommodate the change. The goal of the unit was 10 or fewer SE events for the previous fiscal year; 17 events occurred. Analyzing incident report data showed that 70% of the patients who self-extubated during the period July 2015-March 2017 did not require reintubation. No standardized process had previously existed for evaluating appropriate patients for extubation. This unit is also designated for teaching medical housestaff. This entails monthly rotations of pulmonary/critical care fellows, residents, interns, and medical students. The objectives for this project were to: 1. create a clinical guideline to promote timely controlled planned extubation; 2. present the guideline to medical directors and nursing administration for possible implementation on the unit; 3. provide education on readiness for controlled extubation to nursing staff; 4. disseminate project findings through presentation at the Snowbird Continuing Medical Education (CME) conference. Relevant topics evaluated in the literature review include timely extubation criteria and recommendations, ventilator weaning parameters, sedation types and methods, and problems with prolonged mechanical ventilation. Implementation of project goals included designing the guideline using incident report data, performing root cause analysis for the events, and using information from the literature review along with feedback from the content experts and project chair. Education for unit nursing staff is also a critical component. The guideline was presented at staff meeting in April. In summary, SE is a disruptive event in which a patient removes his or her OETT prematurely before clinicians have deemed it appropriate to discontinue MV therapy. Although it is disruptive, the majority of patients do not require reintubation. This suggests that a timely extubation guideline of objective clinical criteria is appropriate and needed for an expanding medical critical care unit. Committee: Project Chair: Kristi Kissell, DNP, APRN, A-G ACNP-BC Program Director: Denise Ward, DNP, FNP-BC, A-G ACNP-BC Assistant Dean, MS & DNP Programs: Pamela Hardin, PhD, RN, CNE Content Experts: Nathan Hatton, MD and Katherine Layne, BSN, RN, CCRN STANDARDIZED EXTUBATION GUIDELINES Table of Contents 3 Acknowledgements……………………………………………………………………….4 Problem Statement………………………………………………………………………..5 Clinical Significance & Policy Implications…………………………………………......6 Project Objectives………………………………………………………………………...8 Literature Review…………………………………………………………………………8 Theoretical Framework…………………………………………………………………..16 Implementation…………………………………………………………………………..17 Evaluation………………………………………………………………………………..20 Results……………………………………………………………………………………21 Recommendation………………………………………………………………………...24 DNP Essentials…………………………………………………………………………..26 Conclusion……………………………………………………………………………….27 References………………………………………………………………………………..29 Appendix A: Proposal Defense Presentation...…………………………………………..34 Appendix B: Incident Report Data and Patient Outcomes………………………………37 Appendix C: MICU Extubation Guidelines...……………………………………………43 Appendix D: IRB Notification…………………………………………………………...45 Appendix E: Staff Meeting Presentation………………………………………………...47 Appendix F: Staff Education Meeting Questionnaire…………………………………...51 Appendix G: College of Nursing Presentation Poster…………………………………...53 Appendix H: Snowbird Continuing Medical Education Conference Abstract………….55 Appendix I: Email Confirming Submission to Snowbird CME Conference……………58 STANDARDIZED EXTUBATION GUIDELINES Acknowledgements 4 I would like to thank my Project Chair Kristi Kissell, DNP, A-G ACNP-BC, for her support and feedback throughout this project. I would also like to thank my content experts Nathan Hatton, MD, and Katherine Layne, BSN, RN, CCRN, for their vital input and support for the project. Heidi Favero, DNP, A-G ACNP-BC, also provided essential feedback. Classmates Erin Szemak, RN, BSN; Chuck Jarvis, RN, BSN; and Robert Bartlett, RN, BSN, have provided helpful peer feedback. The support of Denise Ward, DNP, FNP-BC, A-G ACNP-BC, Program Director of the Adult-Gerontology Acute Care Nurse Practitioner program within the College of Nursing, and Pamela Hardin, PhD, RN, CNE, Assistant Dean, MS and DNP programs is also appreciated. Nancy Allen, PhD, ANP-BC, was also helpful in providing feedback for my Institutional Review Board application. I would to like to thank my mom, Merrilee Buchanan, who gave me helpful feedback about my presentation. Lastly, I would like to recognize my wife, Laura, and my son, Lucas. Their patience and support for me during this project and the DNP program, in general, has been immeasurable. STANDARDIZED EXTUBATION GUIDELINES 5 Development of Standardized Extubation Guidelines in a Medical Intensive Care Unit Problem Statement Self-extubation (SE) is an event in which an intubated patient receiving mechanical ventilation (MV) removes the endotracheal tube before removal has been deemed clinically appropriate by medical, nursing, and respiratory staff. This problem affects patients who are hospitalized in an Intensive Care Unit (ICU) and have been intubated prior to the event, either due to respiratory failure or altered mental status. When patients self-extubate, it disrupts therapy, and can often lead to emergent reintubation. This is dangerous, as it increases the patient's risk of respiratory arrest or hemodynamic instability. The factors that may lead to a patient self-extubating are complex, related to not only sedation and staffing practices, but also prolonged periods of intubation. In the Medical ICU of an academic teaching hospital in urban Utah, no objective guideline has existed to assess and promote early extubation for appropriate patients. The goal for this project is to offer a solution to this problem by developing an evidencebased guideline to promote early extubation. In addition, this is a teaching unit that consists of medical housestaff (interns, residents, pulmonary fellows) that rotate on a monthly basis. A planned opening of eight additional beds occurred in February (increasing the total number from 17 to 25), and additional nursing staff are either currently training or have recently completed orientation in order to staff the expansion. Unit expansion has also facilitated the creation of two medical teams that oversee patients - the first is the traditional team of medical students, residents, a pulmonary fellow, and STANDARDIZED EXTUBATION GUIDELINES an attending physician, and the second is a team of advanced practice clinicians (APCs) 6 with the oversight of an attending physician. The APC role is similar to that of a pulmonary fellow. Dividing the patients on the unit between the two teams is a recent development, and one that fosters the development of critical care skills of the APCs. The expansion in both area and staff necessitates an objective, standard way to extubate patients safely. The importance of the guideline was realized, in part, by analyzing data from incident reports from previous self-extubations in the intensive care unit to be studied. The goal for the unit was to have fewer than 10 SEs for the fiscal year. There have been 17 SE events, and the majority of the patients do not require reintubation, indicating that they would have benefitted from earlier intervention. These events, and the documented consequences, clearly identify a need for a timely extubation guideline that would fulfill this early intervention. Clinical Significance & Policy Implications Indications for intubation and mechanical ventilation include the patient's inability to maintain airway patency, inability to protect against aspiration, ventilatory compromise, decreased ability to oxygenate blood at the pulmonary-capillary level, and anticipation of a clinical deterioration that will lead to inability to maintain the airway (Lafferty, 2017). Insertion of an oral endotracheal tube (OETT) (or endotracheal tube [ETT]) is a method to establish a reliable airway in a compromised patient. Intubated patients who receive mechanical ventilation stay in an intensive care unit (ICU) and are closely monitored. STANDARDIZED EXTUBATION GUIDELINES Complications of endotracheal intubation include aspiration, esophageal 7 intubation, dental injury, and pneumothorax. These occurred in approximately 10% of 3,400 intubations (Hyzy, 2017). After insertion of the OETT, as mechanical ventilation commences, additional complications may occur. These include ventilator-acquired pneumonia (VAP) and barotrauma (Hyzy, 2017). In addition, laryngeal injury, mucosal injury, and vocal cord paralysis can occur as a result of intubation (Hyzy, 2017). SE occurs in about 3 to 12 percent of intubated patients, about 50% of whom will require reintubation (Hyzy, 2017a). This will also prolong their ICU stay, and increase hospital mortality. Factors in SE include sedation/agitation levels, the securement of the OETT, and physical restraints (Hyzy, 2017a). Unnecessary prolongation of mechanical ventilation increases risk of respiratory infections, deconditioning, barotrauma and cardiovascular compromise (Cabello, RocheCampo, & Mancebo, 2011). Self-extubation and subsequent reintubation increases the chance of aspiration pneumonia (Rashkin & Davis, 1986). In one study, 62% of patients admitted to medical ICUs had evidence of acute delirium during their stay, and inability to communicate is a risk factor for delirium (Balas et al., 2012). Prolonged periods of mechanical ventilation are associated with greater hospital length of stay and greater cost (Zilberberg, Luippold, Susky, & Shorr, 2008). Based on 2005 data, the estimation of the economic effects of prolonged MV (defined as either 21 or more days of MV or 4 days plus placement of a tracheostomy), annual expenditures for Medicare-eligible patients exceeded $20 billion, and this does not include payments to long-term acute care, rehabilitation and skilled nursing facilities (Cox, Carson, Govert, Chelluri & Sanders, STANDARDIZED EXTUBATION GUIDELINES 2007). Also, in terms of long-term effects, fewer than 50% of prolonged MV patients 8 survived more than 1 year (Cox, et al, 2007). The primary goal of this project is to develop evidence-based guidelines in an effort to reduce SE rates for mechanically ventilated patients who are hospitalized in a medical ICU at an urban Utah academic hospital. This will provide standardization in a unit with rotating house compounded with planned expansion, improve patient safety, decrease length of stay and decrease health care costs. Project Objectives The objectives for this project are as follows: 1. Create clinical guidelines to promote early planned extubation in MICU. 2. Present guidelines to the medical directors and nursing administration for possible impementation. 3. Provide education for controlled extubation guidelines to unit nursing staff. 4. Submit project findings for presentation to a Continuing Medical Education conference. Literature Review The literature review search terms included the following terms: "early extubation criteria," "early extubation recommendations," "risks for self-extubation," "risks for reintubation," "ventilator weaning parameters," "sedation methods," "sedation types," and "problems with prolonged mechanical ventilation." Primarily, the literature search focused on articles published within the past 5 years, unless an earlier article was referenced to provide definition for terms used. Databases utilized for the literature search include CINAHL, PubMed, ClinicalKey, and UptoDate. STANDARDIZED EXTUBATION GUIDELINES Timely Extubation Criteria/Recommendations 9 In weaning from mechanical ventilation, observation of clinical criteria is important to monitor the patient's status. "Weaning" can be described as the process of decreasing ventilator support and allowing patients to assume a greater proportion of their respiratory effort. This process can take place in either a gradual or immediate shift from a "control" mode to a "support" mode (Epstein & Walkey, 2017). Typically, pressure support ventilation allows the patient to breathe at his or her own rate but can provide oxygenation and both inspiratory and expiratory support. A spontaneous breathing trial (SBT) is a test in which a patient's ventilator support is turned down to minimal settings for a set time (typically, about 30 minutes) (Epstein & Walkey, 2017). Objective criteria that may indicate failure of weaning include: tachypnea, respiratory distress, hemodynamic changes (such as hypotension or tachycardia), pulse oxygenation of less than 90%, agitation, and somnolence (Epstein & Walkey, 2017). Boles et al. (2007) also state that most studies define extubation and reintubation within 48 hours as weaning failure. The decision to wean toward extubation is at the judgment of the clinician as well. It is important to continue to attempt daily or bi-daily SBTs if the patient fails initially. Failure of extubation is associated with high mortality rate (Boles et al., 2007). It is important to realize that physiological decompensation may impair a patient's ability to successfully wean from the ventilator. Boles et al. (2007) indicated various system disorders that impair successful liberation from mechanical ventilation. Cardiopulmonary issues may develop due to underlying illness, new injury, or ventilator asynchrony. The patient may suffer decreased neuromuscular competence and lack the strength to ventilate without the support (Boles et al., 2007). Also, psychological issues, STANDARDIZED EXTUBATION GUIDELINES such as anxiety, delirium, and depression, are common comorbidities that prevent 10 successful weaning. In addition, metabolic, nutrition, and endocrine disturbances can impair energy and promote instability with a patient undergoing MV. All of these physiological factors are to be considered with weaning, and can impair success. Ventilator Weaning Parameters A meta-analysis conducted by Burns, Adhikari, Keenan, & Meade (2009) examined 12 trials in which intubated COPD patients with prior difficulty weaning had been weaned using non-invasive ventilation. The patients extubated directly to noninvasive ventilation, defined in the study as using a positive pressure ventilation with a patient-ventilator interface of an oronasal, nasal, or total facemask (Burns et al., 2009). The authors of this meta-analysis found that there was an associated decrease in mortality and ventilator-acquired pneumonia with non-invasive weaning. Weaning the ventilator is most often done in a gradual fashion, with gradual changes in the inspiratory pressure (PIP), expiratory pressure (PEEP), and FiO2. In conversations with the intensivist attending for the MICU, he has stated that he will support a guideline with PEEP of less than 8 cm H2O, PIP of less than 12 cm H2O, and fraction of inspired oxygen (FiO2) less than 50%. Typically, patients are extubated on low levels of PEEP, 5 to 8 cm H2O. PEEP is defined as the alveolar pressure above atmospheric pressure that exists at the end of expiration, of which there are two types - extrinsic (supplied by mechanical ventilation) and intrinsic (incomplete expiration) (Sagana & Hyzy, 2017). In terms of patients who are mechanically ventilated, increased PEEP can be used for improved oxygenation in patients with certain pathological states, such as acute respiratory distress syndrome STANDARDIZED EXTUBATION GUIDELINES 11 (ARDS). However, increased PEEP can also cause complications, such as barotraumatic injury to the alveoli, and hemodynamic instability due to increased thoracic pressure (Sagana & Hyzy, 2017). With patients undergoing routine mechanical ventilation, PEEP of 5 to 8 was associated with lower incidence of VAP and hypoxia than no PEEP (Sagana & Hyzy, 2017). While the authors give a range of PEEP from 5 to 8 for routine mechanical ventilation, it is common to expect a PEEP of 5 when preparing to extubate a patient for unit practice. Sedation Types In evaluating the literature to determine contributing factors to SE, certain factors emerge as critical elements. Both the type of sedation medications used and whether the usage is continuous or intermittent are factors in controlling patient comfort and preventing agitation. Keeping a patient deeply sedated will increase safety and reduce the risk of unplanned extubation, but may also keep a patient intubated and requiring mechanical ventilation for a longer duration, increasing their immobility, and putting them at a higher risk for acute delirium. Baron et al. (2015) conducted an extensive literature review that looked specifically at guidelines for sedation, analgesia, and delirium in intensive care units. This review looked specifically at the positive and negative attributes of each medication that is traditionally used to sedate a patient, while being mindful of the ultimate goals: weaning from the ventilator and preventing acute delirium (Baron et al., 2015). The authors concluded that analgesia is a first-line priority over sedation. Riker & Fraser (2009) agreed with these findings, and for sedation, it is their preference that dexmedetomidine (Precedex) is chosen before sedatives like propofol and STANDARDIZED EXTUBATION GUIDELINES 12 benzodiazepines like lorazepam and midazolam. Gupta, Sigh, Sood, & Kathuria (2015) confirmed the superior role of dexmedetomidine in assisting with early extubation in comparison with benzodiazepines. The authors found that the reasons for this included lack of respiratory depression, hemodynamic stability, and easy arousability. Sedation Methods While the type of medication is an important consideration, perhaps equally important are the methods the medical staff utilizes to keep the patient sedated. Sedation practice is a collaborative practice between medical and nursing staff, as the provider will order the medications used and the nursing staff will titrate the medication to sedation goals. A variety of practices and protocols are used for sedation. In evaluation of various sedation protocols, Bugedo et al. (2013) found that while a nursing-driven analgesiabased sedation protocol was safe to use for sedation in mechanically ventilated patients in intensive care, there was ultimately no difference in outcomes. Abdar et al. (2013), in a randomized controlled trial, evaluated sedation practices in an Iranian hospital. Mechanically ventilated patients were randomized to either routine care, or a sedation protocol (Abdar et al., 2013). Results of the study showed that a sedation protocol was useful in reducing administered doses of midazolam and morphine (Abdar et al., 2013). Sneyers, Laterre, Perreault, Wouters, & Spinwine (2014) extensively surveyed nurses and physicians in Belgium, evaluating the differing attitudes in regards to sedation practice. While physicians tended to favor usage of sedation scales more often than nurses, nurses tended to have a more practical view of sedation practices than physicians (Sneyers et al., 2014). More nurses than physicians agreed with the idea that a daily sedation interruption is contraindicated in patients with hemodynamic instability; it STANDARDIZED EXTUBATION GUIDELINES impairs patient comfort, and increases the risk of self-extubation (Sneyers et al., 2014). 13 The study revealed that differing attitudes among clinicians may represent a challenge in the safety and effectiveness of patient sedation. Ranzani, Simpson, Augusto, Cappi, & Noritomi (2014) reproduced the benefits found in other studies when they studied the physiological effects of light sedation against continuous sedation in a multicenter improvement project. They found that from a long-term physiological standpoint, light sedation is preferred. A daily interruption of sedation has long been considered important for patients who are receiving continuous sedation. This allows the clinician to reorient the patient, assess mental status, assess for delirium, and practice ambulation and/or other mobility exercises. However, Mehta et al. (2012), in a randomized control trial and multicenter study of 430 patients in the United States and Canada, found that the addition of a daily sedation interruption did not reduce ventilator time or ICU stay. Problems with Prolonged Mechanical Ventilation Complications associated with endotracheal intubation and mechanical ventilation include both mechanical injury associated with tube pressure on the tissues, medical decompensation from immobilization, and psychological trauma and delirium from prolonged ventilation periods. The pressure of the ETT cuff should be checked routinely (daily, at minimum). Too little pressure can create a cuff leak, which can lead to too little ventilation, secretions escaping down the trachea, and aspiration pneumonia (Hyzy, 2016). Too much pressure can lead to ischemia, ulceration, and tissue necrosis (Hyzy, 2016). Laryngeal injury is the most common complication associated with ETT placement (Hyzy, 2016). Another concern with patients who are intubated is related to STANDARDIZED EXTUBATION GUIDELINES 14 infection and developing VAP. Nursing staff must also be consistent with suctioning both the ETT and the oropharynx, as excessive secretions can lead to VAP. Also, oral decontamination with antiseptics like chlorhexedine is also recommended in prevention of VAP (Hyzy, 2016). Spontaneous Breathing Trial Terms and Considerations The Rapid-Shallow Breathing Index (RSBI) is measured in patients who do not tolerate spontaneous breathing, and this is represented by the ratio of respiratory rate to tidal volume (RR/Vt) (Marino, 2007). A normal ratio is typically 20 to 40/L, and a positive predictive value of 80% having a RR/Vt ratio of 100/L or less when weaning toward extubation (Marino, 2007). RSBI is used in the SBT that the RT will perform, and he or she will utilize this data as part of the picture to determine readiness for extubation. For the purposes of this project, the goal RSBI is less than 100, but that may be flexible and used in consideration with other factors. In general, Marino (2007) recommends a 30- to 120-minute trial of spontaneous breathing, and failure or success is judged by a combination of patient appearance, breathing pattern, and gas exchange (evaluation of oxygen saturation, and, if applicable, end-tidal CO2). About 80% of patients who can tolerate 30 to 120 minutes of spontaneous breathing can be successfully removed from the ventilator (Marino, 2007). Possible Barriers to Extubation Failure to extubate may mean that the patient has not yet recovered from the underlying respiratory disease. If a patient fails an SBT, it is important to continue to try every shift to further assess for readiness. Conditions that may decrease a patient's ability to successfully pass an SBT include a low cardiac output state, overfeeding via tube STANDARDIZED EXTUBATION GUIDELINES 15 feeds, respiratory muscle weakness, and depletion of electrolytes - such as magnesium and phosphorus - that affect the respiratory muscles (Marino, 2007). A 2004 study by Salam, Tilluckdhary, Amoateng-Adjepong, and Manthous found that the ability to extubate a patient is based on neurologic function, cough peak flows (CPF) (or cough strength), and endotracheal secretions. These factors affected the extubation outcomes of patients who passed an SBT. Patients with secretions of 2.5 mL/hr or more were three times more likely to fail than those with less than 2.5 ml/hr; low CPF (less than 60 L/min) patients were five times more likely to fail than patients with CPF of greater than 60 L/min; and patients unable to complete four simple tasks (open eyes, track with eyes, grasp hand, stick out tongue) were four times more likely to fail than those who could follow these commands (Salam, et al., 2004). This was a small study (n=88), but a 2016 study by Lai, Chen, Chiang, Liu, Weng, Sung, Hsing, & Cheng, evaluated 6,583 patients between 2005 and 2014, and determined that 403 patients (6.3%) had extubation failures, or had to be reintubated within 48 hours. The predictors of whether or not an individual would fail extubation in this study included age, gender, disease severity (APACHE II score), level of consciousness, maximal expiratory pressure (MEP) of greater than 55 cm H20, cuff leak test (CLT) of 2+, and RSBI of <68 /L (Lai et al., 2014). They determined the most accurate predictors were MEP, RSBI, and CLT (Lai et al., 2014). Evaluation of an Extubation Protocol The surgical intensive care unit (SICU) at the same institution has a registered nurse (RN)-respiratory therapist (RT) driven extubation protocol in place and evaluation of that has been helpful for looking at the creation of one for the medical ICU. Their STANDARDIZED EXTUBATION GUIDELINES 16 guidelines are for daily SBTs on all stable patients with PEEP <8 and FiO2 <50% (SICU Leadership, n.d.). With this protocol, the RN and RT will communicate daily to perform a sedation vacation/SBT on appropriate patients at 0400 (SICU Leadership, n.d.). The protocol within this institution has been a helpful guide, even as this project's guideline focuses on both the unique patient population and observation of factors of SE occurrences for the medical ICU. Theoretical Framework The diffusion of innovations theory addresses how ideas and social practices that are perceived as "new" can spread throughout a society (National Cancer Institute [NCI], 2005). This is a multilevel change process that involves starting programs or altering personnel roles (NCI, 2005). According to the theory, created by E.M. Rogers, promotion of a new program takes into account the relative advantage over the previous beliefs, compatibility with the intended audience, the complexity of implementation, the trialability, or whether it can be tried as an experimental basis, and observability, whether it can produce results (NCI, 2005). The diffusion of innovations theory is an appropriate framework for the development of an early extubation guideline, as it addresses changing an organizational culture. Ventilator weaning and the decision to extubate a patient has mainly been made by the attending physician or pulmonary fellow. The goal of this project is to create an objective extubation guideline that can be followed by nursing staff and respiratory therapy. This guideline includes exclusion and diagnostic criteria that can help guide the decision-making process, with all members of the interdisciplinary team able to advocate for early extubation for appropriate patients. STANDARDIZED EXTUBATION GUIDELINES This guideline is a patient-focused intervention that has been developed. The 17 diffusion of innovations theory predicts that staff will have varying degrees of receptiveness to change in practice (or any change). The roles that staff will take range from innovators and early adopters (or those who develop and embrace change immediately) to laggards (the last people to adopt a new practice) (NCI, 2005). This bell curve will be an important consideration for staff receptiveness during the initial presentation to staff. Implementation In October 2016, faculty at the University of Utah's College of Nursing approved the project proposal to study root cause analysis of SE events that occurred in the studied ICU over the period of July 2015 to March 2017 and formulate a guideline to promote early planned extubations on the unit. The proposal defense PowerPoint is included as Appendix A. Twenty-three SE incidents occurred during the period of July 2015 to March 2017, and these incident reports were collected and sent by the hospital's patient safety department. These descriptions of the events are brief, but they include the date and time, whether the patient was restrained, whether sedation was used, and a brief description of how the incident occurred. For a more in-depth look at conditions surrounding and follow-up time after these specific incidents, an Institutional Review Board (IRB) application was submitted so that an electronic medical record review for each patient involved in a SE event could be performed. The IRB determined that this project did not meet the definitions of Human Subject Research; therefore, IRB oversight was not required (see Appendix D). STANDARDIZED EXTUBATION GUIDELINES Data for each SE are collected in Appendix B. The data for each event comes 18 from the RN's account of the incident, and most of the description is in the RN's original language. Information for the final column, "outcomes," comes from chart review performed in late February, after the IRB determined that oversight was not required. Based on information obtained through the process of chart review, demographic information of the patients who self-extubated was obtained. These were patients who underwent ICU hospitalization during the period July 2015 to March 2017. The patients were hospitalized for a variety of reasons, and had a range of diagnoses as their principle problems, but overdose, COPD exacerbation, and sepsis were common underlying their respiratory failure and/or altered mental status. The age range was 30-71, and the median age was 55. The patients were 34% female, 66% male. Root cause analysis of these events has determined that the simplified "cause" of their SE event was due to problems with sedation (55%), supervision (22%), family or staff interference (9%), and other or unknown (22%). The guideline was developed by using a blueprint of the surgical ICU's guideline, along with feedback from medical director about acceptable ventilator settings for consideration of the patient population, and awareness of common root causes of SE as collected from the incident reports. A rough draft of the planned guidelines was submitted to the content expert/medical co-director of the ICU in early February, and he expressed support for the project and the specific guidelines. He also posed the question of how many SBT criteria will be included to measure a patient's success, as RSBI, negative inspiratory force (NIF), respiratory rate (RR), and tidal volumes (Vt) are traditionally taken into consideration. Also, the patient must follow commands and have STANDARDIZED EXTUBATION GUIDELINES an audible cuff leak when the OETT cuff is deflated. The more of these categories that 19 are fulfilled, the more successful outcome the patient will have. Traditionally, the RT staff on the unit performs the SBT and will communicate these values to the physicians. In discussion with an RT team member, each of the following criteria should be met for a patient to pass an SBT: vital capacity (the volume of a deep breath) should be greater than or equal to 1 liter, RR should be less than or equal to 30, RSBI less than 100/L, NIF more negative than -20 cm H2O. The patient should also be alert, able to follow commands, and have the strength to lift their head of the pillow. Nursing staff should also be familiar with these terms and understand why their patient has either passed or not passed their SBT. The education conducted during the April staff meeting covered this topic as part of the extubation guideline. The educational PowerPoint was presented in the April staff meeting. The PowerPoint was submitted to Project Chair for approval prior to the presentation. The PowerPoint was developed utilizing the data from the incident reports and follow-up chart review. The educational PowerPoint is included as Appendix E. A follow-up questionnaire to assess staff members' feelings about the usefulness and feasibility of the guideline is included as Appendix F. This questionnaire asks Likert scale questions, based on a five-point scale of "strongly agree" to "strongly disagree." The questionnaire was completed by staff members who were physically present at the meeting. The abstract for the project was submitted for consideration to the Snowbird Continuing Medical Education conference (August 9-11). This is an appropriate venue for dissemination of the guideline, as the audience is comprised of APCs, many of whom work in critical care. STANDARDIZED EXTUBATION GUIDELINES Evaluation 20 Objective 1: Create clinical guidelines to promote early planned extubation in MICU. A rough draft of the guideline was submitted to the content experts and program chair. Feedback obtained from program chair was supportive. Feedback from both content experts was received. The second content expert consulted for this project is a member of the unit nursing management team - comments are noted below. Objective 2: Present guidelines to the medical directors and nursing administration for possible impementation. Feedback obtained from one member of unit nursing management team also provided the question of whether it would be safe to extubate if PEEP is greater than 5 or 6 (up to 8). This question has been evaluated in the literature review, in which a range of 5 to 8 was noted for routine mechanical ventilation, but no specificity within that range was identified. It seems reasonable, and safe, to assume that if a patient could tolerate extubation at 8 of PEEP, he or she could also tolerate weaning to 5 prior to SBT. The manager of the unit has expressed his support for both the guideline and presentation of the guideline in staff meeting. Objective 3: Provide education for controlled extubation guidelines to unit nursing staff. This guideline was presented to unit staff during the April staff education meeting. The audience included a unit attending physician, and 10 unit nurses, including management staff. In addition, 25 more nurses called in and listened to the presentation via telephone. A copy of the Powerpoint was included in an email to all staff with the STANDARDIZED EXTUBATION GUIDELINES meeting minutes. After the presentation, questionnaires were distributed to those who 21 were physically present at the meeting. The feedback for the guideline was extremely positive among those who were there and completed the questionnaire (10 were returned). Every question received the response "agree" or "strongly agree" for all the surveys completed (see Appendix F). One interesting point that was discussed by the attending physician who was present was that perhaps limiting patients to pressure support ventilator settings for eligibility is too exclusive. Patients who are on pressure control or even volume control can also be considered. While pressure support is most commonly utilized in practice, it is correct that patients can also be transitioned from volume or pressure control into an SBT. This feedback revealed a higher level of support for the guideline by increasing the inclusivity, and will be a certainly be a consideration for the guideline as it moves closer to unit practice. Objective 4: Submit project findings for presentation to a Continuing Medical Education conference. Project poster was presented on March 31 to students and faculty for the College of Nursing Doctorate of Nursing Practice poster session. The poster that was presented is included as Appendix G. Submission to the Snowbird CME conference occurred by the deadline, and the proof of submission was given to project chair. The abstract for submission, and the confirmation email that it was received, are included as Appendix H and I, respectively. If accepted, the presentation will cover the guideline, as well as the results of incorporating it into the workflow in the subsequent months prior to the conference. STANDARDIZED EXTUBATION GUIDELINES Results 22 There were 23 SE events on the unit from the period July 2015-March 2017. Reports were filled out by ICU staff following the incidents, and these reports are required to be completed by the nursing or medical staff after significant events, including SE. The summaries of these events can be found in Appendix B. The categories of sedation level and level of harm are subjective and may be subject to the authors' opinions. However, through the narrative description, one may get a feel for the incident in question. Of the 23 events, 16 patients did not need to be reintubated within 48 hours. In most cases, they were able to transfer to the floor the following day, and, in some cases, they left the hospital within a few days. Five patients required reintubation within 48 hours. One patient's outcome was difficult to determine due to lack of information in the chart. One patient transferred to palliative care and died 4 days later. For the first objective, the clinical guidelines were created after review of feedback from content expert/medical director, literature, and similar guidelines. The review of incident report data regarding unit SEs was helpful in determining that in most cases, patients who self-extubate do not require reintubation. Chart review, after obtaining IRB approval, confirmed the fact that most of these patients had still not required reintubation 48 hours after the event. Key facilitators to developing this objective were the Project Chair, who provided initial feedback in regards to providing an appropriate focus for the project, and the content expert/medical director, who provided the initial acceptable ventilator settings that he would be comfortable placing in the guideline, and also surveyed other attending physicians who work on the unit to assess their support for the project. STANDARDIZED EXTUBATION GUIDELINES 23 The second objective was to obtain verbal and written feedback from stakeholders on development of the guideline. These individuals included nursing management team members, and medical directors. Measurement of this objective was to evaluate this feedback and incorporate suggestions into the formation of the guideline. A barrier to this objective was that there were sometimes delays in communication or receiving feedback, which also affected the timeline for further development and implementation of the guideline. The third objective was to present a PowerPoint in staff meeting regarding the guideline. This presentation was given on April 19. The staff members were receptive and supportive of the guideline as a communication and education tool, and questionnaire responses confirmed this. Ongoing feedback, support, and participation from staff at all levels are essential to move the guideline into unit practice. The fourth objective was to submit the project for consideration to the Snowbird CME conference. The abstract was submitted by the submission date. If the project is accepted, that will provide the time to allow for implementation on the unit and assess the measure of success in facilitating extubation. It is feasible that, due to the sheer number of recent changes on the unit, trying to begin implementation of the guideline in April or May will be "one too many changes" for unit culture and this may potentially delay implementation. This could be one of the limitations. Further limitations include that while the patient population who underwent a SE is typical of the unit, the number of patients evaluated was small, with 23 patients considered. Although the author of this project is an employee of this unit, this is a quality improvement project, and there are no financial incentives among the employees STANDARDIZED EXTUBATION GUIDELINES to reduce SE events. Therefore, the likelihood of conflict of interest is low. However, 24 there may be some bias in developing the guideline as the goal for the project was originally to reduce SE events. A situation could potentially arise in which the staff was biased toward promoting the guideline, and did not fully consider all the potential negative consequences of early extubation. Potential negative consequences may include pushing a patient toward extubation if he or she is not ready, and/or trying to forgo or limit sedation in order to try to get the patient extubated faster. Awareness of this potential bias in the decision-making process should be considered for the clinical staff on the unit. While the changes to unit workflow with the guideline implementation would be minimal to insignificant, this sentiment is understood and some flexibility regarding the guideline implementation is possible. Still, the guideline would benefit patients, nursing staff, and physicians, so once the guideline is fine-tuned based on feedback received, it is likely to be implemented relatively soon. Recommendation The overall goal in the creation of the extubation guideline was to standardize the process in which a patient is evaluated for readiness for mechanical ventilation discontinuation. Unit staff will utilize this tool as a method to advocate for their patients. Without the guideline, patients are still evaluated often for readiness to extubate; however, the decision to proceed with SBT and move toward extubation has often been a "top-down" decision that was made by the intensivist or the fellow physician. With a guideline to provide objective criteria to follow, the bedside RN can more easily bring data to the interdisciplinary team, and if appropriate, facilitate more efficient weaning. STANDARDIZED EXTUBATION GUIDELINES Ultimately, the covering attending or fellow physician will still likely have the 25 final decision-making ability with the guideline. Evaluating the patient through the guideline should identify any red flags and barriers to extubation, but it is also necessary to perform a risk assessment: If extubation fails and the patient needs to be reintubated, the physician or covering APC must be prepared to reintubate. The term "guideline" was intentionally chosen over a term such as "protocol" because the judgment of the team, including covering physicians, nursing staff, time of day, and level of support, should also be a consideration for the decision to extubate a patient or continue to wait. It may be argued that many of the patients who underwent SE events were weaned toward extubation too slowly, and staff had valid reasons at the time for keeping them intubated. In these situations, it could be argued that there was perhaps too much subjective judgment and not enough reliance on objective criteria. What would be the use of a guideline if, for example, an attending - who rarely provides coverage in the unit - is covering overnight and is not comfortable extubating the patient on their shift, despite guideline success? In this case, the guideline still has a role in that it brings nursing staff to the table in more of an advocacy role. Even if the decision ultimately is to keep the patient intubated overnight, nursing will still be aware of how close the patient is to extubation and will have a better understanding of the circumstances. The recent feedback regarding adding pressure control and volume control ventilator modes to the eligibility of the guideline will have to be closely considered with unit practice. This discussion is an attending physician-level discussion that would vary greatly based on the comfort level of the covering attending. If these other modes are STANDARDIZED EXTUBATION GUIDELINES included in consideration for who is to receive an SBT, the criteria would be based on 26 PEEP, PIP (or set Vt), and FiO2, and would also include those three modes. Support from the unit staff will determine whether the project is continued or abandoned. If implementation is successful, this could easily become a permanent part of unit culture. If adverse events occur, the guidelines outlined by the project would have to be re-evaluated to improve safety measures. From the standpoint of the usage of the extubation guideline as an educational tool, this may end up benefiting the residents more than the nurses, whose rotations in the ICU are relatively short. Although many of them may end up in specialties where they never work in intensive care, principles of oxygenation and ventilation are integral to all medical fields. DNP Essentials Essential I: Scientific Underpinnings for Practice The goals of this project are based on observation of the biologic and physiological properties of patients who require intubation and MV, and how prolonged MV (or unexpected discontinuation) can have harmful effects on the physical and psychological well-being of the patient (American Association of Colleges of Nursing, 2006). The benefits and drawbacks of mechanical ventilation are scientifically complex, and an understanding of respiratory physiology and illness is critical to the development of a guideline. Essential II: Organizational and Systems Leadership for Quality Improvement and Systems Thinking The goals of this project address a target population (intubated patients in a medical ICU) and seek to achieve quality improvement for a unit problem. Lowering STANDARDIZED EXTUBATION GUIDELINES patient costs and promoting optimal health care outcomes are two large goals to which 27 this project will contribute. Essential VIII: Advanced Nursing Practice The development of this guideline acknowledges the complex biophysical, behavioral, economic and institutional factors involved in mechanical ventilation in critically ill patients. Furthermore, it respects the clinical judgment of the critical care bedside nurses as an important part of this solution. The development of the guideline is based on the belief that the nursing staff members of this ICU are trained and competent professionals in a specialty unit, and they would use their knowledge and judgment in a way that benefits patients. Conclusion This project was an effort to develop an evidence-based guideline that would standardize process for critically ill medicine patients by promoting the recognition of ventilator weaning and discontinuation criteria among hospital staff. Sixteen out of 23 patients, or 69.5 percent, who self-extubated during the studied period did not require reintubation within 48 hours. The total number of patients studied is small, but as mentioned previously, decreased SE rates are not the only benefits of timely extubation for patients. As stated before, the goals of this guideline are to develop awareness among the staff regarding a patient's ability to be extubated safely, and to use this awareness to advocate for timely appropriate extubation with the medical team. This guideline is therefore a communication, education, and advocacy tool to be used by staff to prevent SE and to reduce the adverse effects of prolonged MV for these critically ill patients. STANDARDIZED EXTUBATION GUIDELINES The literature review determined the optimal ventilator settings for a patient to 28 progress to, sedation medication types and methods, possible anticipated barriers, and ventilator weaning parameters. The theoretical framework identified a model that can be used as implementation of the guideline is integrated into unit practice. The implementation and evaluation sections have demonstrated the process by which change to practice is made - feedback must be obtained and incorporated from the medical, management, and staff levels. Safety is a major concern in a large 25-bed ICU. Multiple patients are often simultaneously critically ill, and require focus of the staff dedicated to them. Efforts to increase overall unit safety, and improve quality patient outcomes are constantly evaluated. This guideline should be used to evaluate patients for extubation early in the shift, and if appropriate, perform planned extubation for risky patients so that a SE later in the day does not harm the patient or disrupt unit workflow. STANDARDIZED EXTUBATION GUIDELINES References 29 Abdar, M.E., Rafiei, H., Abbaszade, A., Hosseinrezaei, H., Abdar, Z.E., Delaram, M., & Ahmadeinejad, M. (2013). Effects of nurses' practice of a sedation protocol on sedation and consciousness levels of patients on mechanical ventilation. Iranian Journal of Nursing and Midwifery Research, 18(5), 391-395. American Association of Colleges of Nursing. (2006.) The essentials of doctoral education for advanced nursing practice. 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Critical Care Medicine, 36(3), 724-730. doi: 10.1097/CCM.0B013E31816536F7 STANDARDIZED EXTUBATION GUIDELINES Appendix A Proposal Defense PowerPoint 34 STANDARDIZED EXTUBATION GUIDELINES Proposal Defense PowerPoint 35 STANDARDIZED EXTUBATION GUIDELINES 36 Running head: STANDARDIZED EXTUBATION GUIDELINES Appendix B Incident Report Data and Patient Outcomes 38 STANDARDIZED EXTUBATION GUIDELINES Incident Report Data and Patient Outcomes Date Time Sedation Restraints Description 7/12/15 0000 None Unknown 8/6/15 0720 Inadequately On 8/30/15 0100 None Off 9/2/15 1455 Unclear On 9/19/15 0255 Inadequately On 12/14/15 1855 Yes On Patient self extubated. Medical team bagged the patient, NRB. Sats dropped to 61% initially then recovered. RN ran to room. Patient had self extubated with phlebotomy present. Phlebotomist "never notified anyone" Patient pulled out trach after RT left room. Monitored by 1:1 aide sitting in between the two rooms. Trach was put back in to patient. Restraints ordered/applied In hindsight the only way this could have possibly been prevented is to have a sitter with him as he was weaned as he is very strong Happened after repositioning and rerestraining. Sedation medication discussion with covering MD had been and issue throughout the shift. Tightly restrained and on prop/fent gtt 1/12/16 1115 Yes On Pt on ventilator PS 18/7, 40 % oxygen, propofol 30 mcg/kg/min. Patient awake, nodding head appropriately to questions. Restraints on appropriately, pt instructed several times during day to not pull out Endotracheal tube. At 1115, Nurse manager heard vent alarm and found that Level of Harm Temporary Outcomes Not re-intubated within 48 hours. None Not re-intubated within 48 hours. Temporary Not re-intubated within 48 hours. None Discharged from the hospital within 48 hours Discharged the following day None None Temporary Left against medical advice within hours of SE event Not re-intubated within 48 hours. 39 STANDARDIZED EXTUBATION GUIDELINES 2/4/16 0245 None On 2/9/16 2330 Unclear On 3/15/16 1430 None Unclear 3/20/16 0900 Inadequately On patient had pulled out ETT and OGT approx. 4 inches; Restraints were intact. [Pulmonary fellow] in to see patient; Simple mask 8 liters started until bipap available. Racemic epi given for wheezing which helped. ABG's done on 8 liters and bipap 40% 14/8. Both ABG's stable. Pt self extabated at 0245. Pt was found with both restraints tied tightly. Pt not on sedation. Pt had moved down in bed on right side while the tubing of the vent became stuck on the left side. The ventilator did not alarm while the tube was being pulled by the bed. An RN walking by saw that the tube was further out in the patients mouth. MD, RT, RN to bedside. Pt O2 stable on 6L mask. Pt oriented. Patient slid down in bed and pulled ET tube with her tightly restrained arms. RNs responded immediately, but tube was already out. Patient was suctioned and put on NC for O2 therapy. A non-rebreather was on hand and RT and MD responded quickly, but no intervention was needed. Patient was alert and oriented, maintained O2 sats with minimal O2, and stated she "doesn't need help breathing." Pt was to receive hemodialysis that day and team felt dialysis prior to extubation would be beneficial to successful extubation. Patient we not on sedation per teams request Pt. was going to have an SBT to be extubated and when RN and RT were walking into the room pt. pulled out breathing tube. Temporary Not re-intubated within 48 hours. None Transferred to the floor next day and discharged two days later None Transferred to the floor next day. None Undetermined from record 40 STANDARDIZED EXTUBATION GUIDELINES 4/1/16 0415 Unclear On Restraints ordered/applied. Patient pulled her wrist through the restraint and was able to pull her ET tube out. None 5/2/16 1858 Yes On Temporary 5/9/16 2115 Yes On 5/12/16 0020 No On 5/17/16 1615 Yes On Patient wiggled down in bed after being properly sedated all day. He was positioned high up in the bed and restraints secured properly. He wiggled down low enough to grab the ETT and self extubated. I was on the phone updating an OSH MD when I saw multiple staff members run into the room. I followed and patient was re-intubated. At 2115 pt sat up in bed and was able to pull ET tube out. Restraints were still tied and in place. Pt O2 sats were maintained throughout incident. Pt has propofol running and was calm and cooperative when RN left the room. Attempts had been made to extubate the pt earlier in the night but due to end stage renal disease the pt was not clearing sedation enough to pass an SBT without apneic events. Pt was in soft wrist restraints and no sedation and was able to move enough to pull out the ET tube and push the call light to demand water. Staff responded immediately and applied a simple mask at 15L. Pt sats never dropped below 91% and quickly went to 99% once the mask was applied. Self extubated with restraint on and sedated 8/11/16 1555 Yes Off Patient's wife removed left upper extremity restraint without permission or discussion with staff. Patient pulled OETT. Pt was not on sedation None Not re-intubated within 48 hours. Transfer to the floor following day Immediate reintubation None Transfer to the floor that day. Discharged from hospital 3 days later None Transferred to the floor the following day None Re-intubated the following day Not re-intubated within 48 hours. Transferred to the 41 STANDARDIZED EXTUBATION GUIDELINES 9/8/16 0530 Unclear On 10/3/16 2130 Unclear On 10/15/16 1030 No Off 10/18/16 0343 Inadequately On 10/20/16 0600 Yes On as he was intubated for decreased LOC and had remained very obtunded. He was just started to open his eyes and localize RUE to pain. Only withdrawing in LUE and no movement in BLE. Pt appears to have woken up and leaned forward to pull ET tube out. Arms restrained. Pt. slid down in bed where he was able to reach ET Tube with restraints upper limbs and pulled ET Tube out Patient had been intubated but loosely restrained for several shifts. Very appropriate with 0800 assessment so I did not tightly restrain him at the time. Alert and oriented x 4 (communicated through hand gestures, mouthing words) and passed CAM-ICU. CXR obtained about 1020, and 5 min later patient self extubated. Team was urgently called, and BiPAP was applied. Patient seemed to tolerate BiPAP ok. Follow-up ABGs showed that patient was not becoming hypoxic or hypercapnic. Due to high RR and HR, patient was monitored closely for the rest of the shift and this info was passed onto oncoming RN. Patient wiggled down in bed and was able to self extubate with his left hand Another nurse and I were talking just outside room. We heard a cough and went to check the patient. The vent alarm did not sound but the patient was coughing around the ET tube and had floor the following day. None None Not re-intubated within 48 hours. Transferred to the floor the following day. Not re-intubated within 28 hours. None Patient was reintubated within 24 hours None Re-intubated Temporary Re-intubated 42 STANDARDIZED EXTUBATION GUIDELINES 1/29/17 1208 No On managed to push/pull it out about 2 cm. She was restrained but had one finger hooked around the suction tubing. The connection at the ET tube was detached from the ventilator. Attempts were made to reattach and inflate the cuff to provide oxygen but she was still coughing around the vent. The ET tube was pulled and the patient was reintubated. During this time, patient O2 saturation was low for about 10 minutes (between 65-85%). Patient is now sedated, restrained, and ventilating/perfusing just fine Heard yellow alarm, walked in room and ET tube was out of patients mouth, patient was still restrained and able to protect own airway. Put patient on face mask 10L, saturating fine. [Pulmonary intensivist] made aware and in room moments after incident. None Not re-intubated Running head: STANDARDIZED EXTUBATION GUIDELINES Appendix C MICU Extubation Guidelines STANDARDIZED EXTUBATION GUIDELINES Extubation guidelines 44 PURPOSE: To prevent self-extubations on the Medical Intensive Care Unit by offering a RN- and RT-driven guideline to promote timely extubations in appropriate patients. Determine Readiness of the Patient: ventilator settings that acceptable to proceed with exultation: Pressure support or pressure control ventilation. PIP < 12 PEEP < 8 FiO2 < 50% Coordinate care with RT. Coordinate sedation vacation (done q shift) with SBT (if SBT is appropriate) Riker score goal is 4 during sedation vacation/SBT. Ensure patient has adequate supervision while on sedation vacations. Many self-extubations happen during this time. Weaning parameter goals RR <30 Vt > 5 mL/kg RSBI < 60 Follow commands NIF < (More negative than) -30 Positive cuff leak Patients who may be excluded or need more consideration Neuromuscular disease Difficult airway or difficult previous intubation Need for surgery within 24 hours Imaging (CT/MRI) with noncompliant patient. Overdose patients (Half-life of the drug) Following SBT Fail? Assess whether patient can remain unsedated, with the goal to try again later that day Pass? Discuss results with physician and plan to extubate. STANDARDIZED EXTUBATION GUIDELINES Appendix D IRB Notification 45 STANDARDIZED EXTUBATION GUIDELINES IRB Notification IRB: IRB_00097310 PI: Benjamin Bradford Title: Timely Controlled Extubation Guidelines in an Intensive Care Unit Date: 2/17/2017 46 Thank you for submitting your request for approval of this project. The IRB has administratively reviewed your application and has determined on 2/17/2017 that your project does NOT meet the definitions of Human Subjects Research according to Federal regulations. Therefore, IRB oversight is not required or necessary for your project. DETERMINATION JUSTIFICATION: The project does not qualify for the DHHS criteria of Human Subject Research because the proposal constitutes a quality improvement project aimed at improving timely controlled extubation and not a systematic investigation designed to develop or contribute to generalizable knowledge. This project does not meet the FDA definition of Human Subjects Research because it does not involve a drug, device, or any other article regulated by the FDA This determination of non-human subjects research only applies to the project as submitted to the IRB. Since this determination is not an approval, it does not expire or need renewal. Remember that all research involving human subjects must be approved or exempted by the IRB before the research is conducted. If you have questions about this, please contact our office at 581-3655 and we will be happy to assist you. Thank you again for submitting your proposal. STANDARDIZED EXTUBATION GUIDELINES Appendix E Staff Meeting Presentation 47 STANDARDIZED EXTUBATION GUIDELINES Staff Meeting Presentation 48 STANDARDIZED EXTUBATION GUIDELINES 49 STANDARDIZED EXTUBATION GUIDELINES 50 STANDARDIZED EXTUBATION GUIDELINES Appendix F Staff Education Meeting Questionnaire 51 52 STANDARDIZED EXTUBATION GUIDELINES Staff Education Meeting Questionnaire 1. A standardized extubation guideline would help staff to identify ventilated patients who are ready for an SBT Strongly agree Agree Neutral Disagree Strongly Disagree 2. A standardized extubation guidelines would be beneficial for ventilated patients on the unit. Strongly agree Agree Neutral Disagree Strongly Disagree 3. Standardized extubation guidelines would be helpful for communications between disciplines (MDs, APCs, RNs, RTs), and between day and night shift Strongly agree Agree Neutral Disagree Strongly Disagree 4. Standardized extubation guidelines would be a helpful educational tool for new staff Strongly agree Agree Neutral Disagree 5. This is something that is feasible to implement on the unit Strongly agree Agree Neutral Disagree Strongly Disagree Strongly Disagree STANDARDIZED EXTUBATION GUIDELINES Appendix G College of Nursing Presentation Poster 53 STANDARDIZED EXTUBATION GUIDELINES College of Nursing Presentation Poster 54 STANDARDIZED EXTUBATION GUIDELINES Appendix H Snowbird Continuing Medical Education Conference Abstract 55 STANDARDIZED EXTUBATION GUIDELINES 56 Clinical Poster Abstract Development of Standardized Extubation Guidelines in a Medical Intensive Care Unit Ben Bradford, BS, BSN, RN, CCRN STANDARDIZED EXTUBATION GUIDELINES Abstract: Development of Standardized Extubation Guidelines in a Medical Intensive Care Unit 57 Oral endotracheal tube (OETT) intubation is a medical intervention for critically ill medical patients who have lost the ability to maintain their airway, suffer respiratory failure, or have deteriorated clinically to the point at which loss of the ability to protect their airway is imminent. For these patients, intubation and mechanical ventilation (MV) is appropriate. Self-extubation (SE) is an event in which an intubated patient receiving mechanical ventilation removes the endotracheal tube before removal is deemed clinically appropriate. SE disrupts medical treatment and may lead to emergent re-intubation. The ICU studied is a 25-bed unit for critically ill medical patients at an academic hospital in urban Utah. The unit recently expanded from 17 to 25 beds, and this expansion opened February 2017, and new nursing staff is added to accommodate this change. The goal of the unit was 10 or fewer SE events for the previous fiscal year. There were 17 events. Analyzing incident report data shows that 70% of the patients who SE in the during the period July 2015-March 2017 require reintubation. No standardized process has previously existed for evaluating appropriate patients for extubation. This unit is also designated for teaching medical housestaff. This entails monthly rotations of pulmonary/critical care fellows, residents, interns, and medical students. The objectives for this project were to: 1. Create a clinical guideline to promote timely controlled planned extubation and obtain Institutional Review Board approval; 2. Present the guideline to medical directors and nursing administration for possible implementation on the unit; 3. Provide education for readiness for controlled extubation to nursing staff; and 4. Disseminate project findings through presentation at an academic conference. Relevant topics evaluated in the literature review include timely extubation criteria and recommendations, ventilator weaning parameters, sedation types and methods, and problems with prolonged mechanical ventilation. Implementation of project goals included designing the guideline using incident report data, performing root cause analysis for the events, and also using information from the literature review along with feedback from the content experts and project chair. Education for unit nursing staff is also a critical component. The guideline was presented at staff meeting in April. In summary, SE is a disruptive event in which a patient removes his or her OETT prematurely before clinicians have deemed it appropriate to discontinue MV therapy. Although it is disruptive, the majority of patients do not require reintubation. This suggests that a timely extubation guideline of objective clinical criteria is appropriate and needed for an expanding medical critical care unit. STANDARDIZED EXTUBATION GUIDELINES Appendix I Email Confirming Submission to Snowbird CME Conference 58 59 STANDARDIZED EXTUBATION GUIDELINES Email Confirming Submission to Snowbird CME Conference Michael Huntsman [[e-mail]] To: Actions BENJAMIN ERIK BRADFORD Inbox Dear Ben, Friday, April 07, 2017 10:37 AM Thank you for submitting your abstract. I has been made available to a panel of reviewers who will make a decision about having it presented at the SnowbirdCME (NP/PA) conference on Wednesday, August 9th from 6-6:45 PM at the Cliff Lodge at Snowbird Ski & Summer Resort. Mike