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

NCT ID: NCT05505799

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-07

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Intubation, Intratracheal Rapid Sequence Induction and Intubation Checklist

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Before and After study of a Checklist Intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preintervention

Normal clinician intubation process

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

Clinicians will intubate as per their usual practice

Postintervention

Clinician intubation process after implementation and clinician education with a procedural checklist

Group Type EXPERIMENTAL

Intubation Checklist

Intervention Type OTHER

A preprocedure checklist will be made available to clinicians, and they will be educated on proper use of the checklist

Interventions

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Intubation Checklist

A preprocedure checklist will be made available to clinicians, and they will be educated on proper use of the checklist

Intervention Type OTHER

Standard Care

Clinicians will intubate as per their usual practice

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Any patient undergoing endotracheal intubation in the Emergency department

Exclusion Criteria

* Age \< 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Community Medical Center, Toms River, NJ

OTHER

Sponsor Role lead

Responsible Party

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Greg Neyman

Sub-Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Josesph Roarty, MD

Role: PRINCIPAL_INVESTIGATOR

Robert Wood Johnson Barnabas Health Community Medical Center

Locations

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Community Medical Center

Toms River, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31316700 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32614424 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27785883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23574475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26484464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26836712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34344738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22050948 (View on PubMed)

Other Identifiers

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22-020

Identifier Type: -

Identifier Source: org_study_id

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