NCT05505799

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

August 16, 2022

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • First Pass Success Rate

    Proportion of intubations where the trachea is successfully intubated on the first attempt

    At time of intubation

Secondary Outcomes (11)

  • Aspiration rate

    At time of intubation

  • Cardiac arrest

    At time of intubation

  • Cuff Leak

    At time of intubation

  • Dental trauma

    At time of intubation

  • Dysrhythmia

    At time of intubation

  • +6 more secondary outcomes

Study Arms (2)

Preintervention

ACTIVE COMPARATOR

Normal clinician intubation process

Other: Standard Care

Postintervention

EXPERIMENTAL

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

Other: Intubation Checklist

Interventions

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

Postintervention

Clinicians will intubate as per their usual practice

Preintervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient undergoing endotracheal intubation in the Emergency department

You may not qualify if:

  • Age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Related Publications (8)

  • 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.

    PMID: 31316700BACKGROUND
  • 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.

    PMID: 32614424BACKGROUND
  • 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.

    PMID: 27785883BACKGROUND
  • 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.

    PMID: 23574475BACKGROUND
  • 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.

    PMID: 26484464BACKGROUND
  • 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.

    PMID: 26836712BACKGROUND
  • 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.

    PMID: 34344738BACKGROUND
  • 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.

    PMID: 22050948BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Josesph Roarty, MD

    Robert Wood Johnson Barnabas Health Community Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Before and After study of a Checklist Intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sub-Investigator, Clinical Professor

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

July 7, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2025

Last Updated

February 12, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations