Community Medical Center, Continuous Quality Improvement Project, Rapid Sequence Intubation

Study Overview
=================
Brief Summary
-----------------
To assess the ongoing continuous quality improvement of rapid sequence intubation in our emergency department. Ongoing assessment will address standardization of the process and protocol driven measures that will improve the overall quality of the intervention.

Detailed Description
-----------------
Continuous evaluation and improvement of airway performance in the Emergency Department (ED) is essential for achieving positive clinical outcomes and reducing the incidence of related adverse events. First-pass success (FPS) in Rapid Sequence Intubation (RSI) is the most commonly utilized metric for evaluation and allows for comparison across clinical environments. According to a variety of studies published over the last decade, including a large, multi-center systematic review and meta-analysis, the mean FPS rate (84%) has been used as an institutional benchmark for ED airway proficiency. Unfortunately, many complications can arise during RSI, the incidence of which has remained high. These complications commonly lead to poor or life-threatening outcomes and include desaturation, hypotension, dysrhythmia, cardiac arrest, pneumothorax, dental trauma, and esophageal intubation. According to the 4th National Audit Project of the Royal College of Anesthetists, it was determined that 30% of patients in the ED and 60% of patients in the ICU experiencing an airway related incident, suffered brain damage or death. The number of failed intubation attempts (3+) has been directly correlated with the an increased development of complications. Thus, establishing effective methods of decreasing the occurrence of failed attempts will result in an immediate reduction of unintended issues. To maximize FPS and increase the safety of the procedure, it is essential to develop a tool to maximize efficacy. The introduction of checklists as a process improvement tool has been identified as a successful strategy for improving the effectiveness and quality of procedures throughout healthcare. Integration of a checklist in the RSI procedure will help to increase FPS rates and act as a method to aid in continuous evaluation and improvement of overall airway performance. Although many airway performance improvement studies exist, our institution is unique in that we are a new Emergency Medicine (EM) Residency program that will be comprised of only post-graduate year 1 (PGY1) and post-graduate year 2 (PGY2) EM residents at the commencement of data collection. Furthermore, our clinical skills training process involves an integrative approach, pioneered by our interdisciplinary team of educators. Continuous evaluation of FPS and the incidence of RSI-related complications will allow for assessment of not only our quality improvement initiative, but of our educational methodology as well. Overall, implementation of quality and performance improvement strategies can mitigate the occurrence of adverse events and lead to improved health outcomes for our patients. This is of paramount importance to us as providers and to our community as a whole.

Official Title
-----------------
Community Medical Center, Continuous Quality Improvement Project, Rapid Sequence Intubation

Conditions
-----------------
Checklist, Intubation, Intratracheal, Rapid Sequence Induction and Intubation

Intervention / Treatment
-----------------
* Other: Intubation Checklist
* Other: Standard Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient undergoing endotracheal intubation in the Emergency department Exclusion Criteria: Age < 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Before and After study of a Checklist Intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preintervention<br>Normal clinician intubation process | Other: Standard Care<br>* Clinicians will intubate as per their usual practice<br>|
| Experimental: Postintervention<br>Clinician intubation process after implementation and clinician education with a procedural checklist | Other: Intubation Checklist<br>* A preprocedure checklist will be made available to clinicians, and they will be educated on proper use of the checklist<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Pass Success Rate | Proportion of intubations where the trachea is successfully intubated on the first attempt | At time of intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspiration rate | Proportion of intubations where patients suffer aspiration | At time of intubation | 
| Cardiac arrest | Proportion of intubations where patients suffer cardiac arrest | At time of intubation | 
| Cuff Leak | Proportion of intubations where the endotracheal tube experiences a cuff leak | At time of intubation | 
| Dental trauma | Proportion of intubations where patients suffer dental trauma | At time of intubation | 
| Dysrhythmia | Proportion of intubations where patients suffer dysrhythmia | At time of intubation | 
| Esophageal intubation | Proportion of intubations where patients encounter esophageal intubation | At time of intubation | 
| Unplanned extubation | Proportion of intubations where patients encounter an unplanned extubation | At time of intubation | 
| Post procedural hypotension | Proportion of intubations where patients suffer hypotension in the immediate postprocedure period | At time of intubation | 
| Hypoxemia | Proportion of intubations where patients suffer hypoxemia | At time of intubation | 
| Laryngospasm | Proportion of intubations where patients suffer laryngospasm | At time of intubation | 
| Mainstem intubation | Proportion of intubations where patients encounter a mainstem intubation | At time of intubation |