Airway Management in the Intensive Care and Regular Hospital Units During COVID-19 Pandemic

Sponsor
American University of Beirut Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04769154
Collaborator
(none)
100
1
23
4.3

Study Details

Study Description

Brief Summary

The aim of this descriptive observational study is to evaluate endotracheal intubation during COVID-19 pandemic at the AUBMC outside the OR (excluding the Emergency Department (ED)) and compare the success and complication rates with previous literature and international benchmarks. The investigators will assess the rate of successful endotracheal intubations at first attempt, the total number of attempts at endotracheal intubation, the devices used for endotracheal intubation (direct laryngoscopy, video laryngoscopy, endotracheal boogie, Fiber optic etc.…), the anesthetic drugs given before intubation, the Cormack-Lehane score (compared with previous score if present for the same patient), the MACOCHA score in addition to the complication rates including but not limited to events of hypotension (SBP < 80 mmHg), severe hypoxemia (SpO2 < 85%), respiratory or cardiac arrest.

The investigators hypothesize that endotracheal intubation outside the OR at AUBMC has higher success rates and lower complication rates as compared to the literature. The investigators believe this is due to the fact that the devices and teams available for intubation outside the OR are highly efficient and very versatile compared to other facilities.

The primary outcome of this study is to assess the success rate of endotracheal intubation at first attempt outside the operating room with direct laryngoscopy or with the use of an assisting device. The secondary outcomes will identify adverse events; mainly hypoxemia (SpO2 < 85%) and hypotension (SBP < 80 mmHg).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Airway Management in the Intensive Care and Regular Hospital Units During COVID-19 Pandemic: A Prospective Observational Study
    Actual Study Start Date :
    Mar 2, 2021
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The success rate of endotracheal intubation at first attempt [During endotracheal intubation]

      The success rate of endotracheal intubation at first attempt outside the OR with direct laryngoscopy or the use of an assisting device

    Secondary Outcome Measures

    1. Adverse events (Hypoxemia) [During the procedure]

      Hypoxemia (SpO2 < 85%)

    2. Adverse events (Hypotension) [During the procedure]

      Hypotension (SBP < 80 mmHg)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing elective or emergent intubation on regular floors or ICU or COVID patients.

    • Patients above 18 years of age.

    • Intubation done by an anesthesia provider with at least 2 years of experience

    Exclusion Criteria:
    • Patients in the ED.

    • Patients intubated by non-anesthesia providers.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AUBMC Beirut Lebanon

    Sponsors and Collaborators

    • American University of Beirut Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Marie Awad, Professor and Chairperson, American University of Beirut Medical Center
    ClinicalTrials.gov Identifier:
    NCT04769154
    Other Study ID Numbers:
    • BIO-2020-0049
    First Posted:
    Feb 24, 2021
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2021