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

Not Applicable

Active, not recruiting

• Conditions: Rapid Sequence Induction and Intubation; Intubation, Intratracheal; Checklist
• Interventions: Other: Standard Care; Other: Intubation Checklist

• Registration Number: NCT05505799
• Lead Sponsor: Community Medical Center, Toms River, NJ

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.

Study Timeline

• Study Start: 2022-07-07
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-18
• Status Verified: 2024-02
• Primary Completion: 2024-06-30
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Any patient undergoing endotracheal intubation in the Emergency department

Exclusion Criteria

• Age < 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Preintervention	Standard Care	Normal clinician intubation process
Postintervention	Intubation Checklist	Clinician intubation process after implementation and clinician education with a procedural checklist

Primary Outcome Measures

Name	Time	Method
First Pass Success Rate	At time of intubation	Proportion of intubations where the trachea is successfully intubated on the first attempt

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Community Medical Center; 🇺🇸 Toms River, New Jersey, United States