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

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.

Study Overview

• Status: Recruiting
• Conditions: Intubation, Intratracheal; Rapid Sequence Induction and Intubation; Checklist
• Intervention / Treatment: Other: Standard Care; Other: Intubation Checklist

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 Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josesph Roarty, MD; Phone Number: 732-557-8185; Email: Joseph.Roarty@rwjbh.org

Study Locations

• United States
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Recruiting
      • Community Medical Center
      • Contact: John Woods; Phone Number: 732-557-8185; Email: John.Woods@rwjbh.org
      • Principal Investigator: Joseph Roarty, MD
      • Sub-Investigator: Nicole Maguire, DO
      • Sub-Investigator: Greg Neyman, MD
      • Sub-Investigator: Travis Masood, MD
      • Sub-Investigator: Nileena Johnkutty, DO
      • Sub-Investigator: Hrant Gevorgian, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any patient undergoing endotracheal intubation in the Emergency department

Exclusion Criteria:

• Age < 18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Preintervention; Normal clinician intubation process	Other: Standard Care; Clinicians will intubate as per their usual practice
Experimental: Postintervention; 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

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

Collaborators and Investigators

• Sponsor: Community Medical Center, Toms River, NJ
• Investigators: Principal Investigator: Josesph Roarty, MD, Robert Wood Johnson Barnabas Health Community Medical Center

Publications and helpful links

General Publications

• Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.
• Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
• Sakles JC, Mosier JM, Patanwala AE, Arcaris B, Dicken JM. First Pass Success Without Hypoxemia Is Increased With the Use of Apneic Oxygenation During Rapid Sequence Intubation in the Emergency Department. Acad Emerg Med. 2016 Jun;23(6):703-10. doi: 10.1111/acem.12931. Epub 2016 May 13.
• Sakles JC, Augustinovich CC, Patanwala AE, Pacheco GS, Mosier JM. Improvement in the Safety of Rapid Sequence Intubation in the Emergency Department with the Use of an Airway Continuous Quality Improvement Program. West J Emerg Med. 2019 Jul;20(4):610-618. doi: 10.5811/westjem.2019.4.42343. Epub 2019 Jun 3.
• Turner JS, Bucca AW, Propst SL, Ellender TJ, Sarmiento EJ, Menard LM, Hunter BR. Association of Checklist Use in Endotracheal Intubation With Clinically Important Outcomes: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jul 1;3(7):e209278. doi: 10.1001/jamanetworkopen.2020.9278. Erratum In: JAMA Netw Open. 2020 Jul 1;3(7):e2016899.
• Park L, Zeng I, Brainard A. Systematic review and meta-analysis of first-pass success rates in emergency department intubation: Creating a benchmark for emergency airway care. Emerg Med Australas. 2017 Feb;29(1):40-47. doi: 10.1111/1742-6723.12704. Epub 2016 Oct 27.
• Bernhard M, Becker TK, Gries A, Knapp J, Wenzel V. The First Shot Is Often the Best Shot: First-Pass Intubation Success in Emergency Airway Management. Anesth Analg. 2015 Nov;121(5):1389-93. doi: 10.1213/ANE.0000000000000891. No abstract available.
• Gopinath B, Sachdeva S, Kumar A, Kumar G. Advancing emergency airway management by reducing intubation time at a high-volume academic emergency department. BMJ Open Qual. 2021 Jul;10(Suppl 1):e001448. doi: 10.1136/bmjoq-2021-001448.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No