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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04769154
Recruitment Status : Not yet recruiting
First Posted : February 24, 2021
Last Update Posted : February 26, 2021
Information provided by (Responsible Party):
Dr. Marie Awad, American University of Beirut Medical Center

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
Airway Management Intensive Care Unit Covid19

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Airway Management in the Intensive Care and Regular Hospital Units During COVID-19 Pandemic: A Prospective Observational Study
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The success rate of endotracheal intubation at first attempt [ Time Frame: 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) [ Time Frame: During the procedure ]
    Hypoxemia (SpO2 < 85%)

  2. Adverse events (Hypotension) [ Time Frame: During the procedure ]
    Hypotension (SBP < 80 mmHg)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients requiring elective or emergent endotracheal intubation

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.
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Responsible Party: Dr. Marie Awad, Professor and Chairperson, American University of Beirut Medical Center Identifier: NCT04769154    
Other Study ID Numbers: BIO-2020-0049
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No