An interventional study of Intubation Checklist and Standard Care in Intubation, Intratracheal, Rapid Sequence Induction and Intubation and Checklist, sponsored by Community Medical Center, Toms River, NJ. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Community Medical Center, Toms River, NJ · Not applicable, Interventional, and Treatment
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.
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.
Community Medical Center, Toms River, NJ is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Normal clinician intubation process
Other: Standard Care
Clinician intubation process after implementation and clinician education with a procedural checklist
Other: Intubation Checklist
A preprocedure checklist will be made available to clinicians, and they will be educated on proper use of the checklist
Clinicians will intubate as per their usual practice
First Pass Success Rate
Proportion of intubations where the trachea is successfully intubated on the first attempt
Time frame: At time of intubation
Aspiration rate
Proportion of intubations where patients suffer aspiration
Time frame: At time of intubation
Cardiac arrest
Proportion of intubations where patients suffer cardiac arrest
Time frame: At time of intubation
Cuff Leak
Proportion of intubations where the endotracheal tube experiences a cuff leak
Time frame: At time of intubation
Dental trauma
Proportion of intubations where patients suffer dental trauma
Time frame: At time of intubation
Dysrhythmia
Proportion of intubations where patients suffer dysrhythmia
Time frame: At time of intubation
Esophageal intubation
Proportion of intubations where patients encounter esophageal intubation
Time frame: At time of intubation
Unplanned extubation
Proportion of intubations where patients encounter an unplanned extubation
Time frame: At time of intubation
Post procedural hypotension
Proportion of intubations where patients suffer hypotension in the immediate postprocedure period
Time frame: At time of intubation
Hypoxemia
Proportion of intubations where patients suffer hypoxemia
Time frame: At time of intubation
Laryngospasm
Proportion of intubations where patients suffer laryngospasm
Time frame: At time of intubation
Mainstem intubation
Proportion of intubations where patients encounter a mainstem intubation
Time frame: At time of intubation
Plan to share: No
Ran from Jul 2022 to primary completion in Jun 2024, 23 months.
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This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Community Medical Center, Toms River, NJ