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CompletedNCT04769154Updated Aug 9, 2024

Adult Airway Management in the Intensive Care Units and Regular Floors

An observational study in Airway Management and Intensive Care Unit, sponsored by American University of Beirut Medical Center. Completed at 1 site in Lebanon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by American University of Beirut Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
199
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this prospective observational study is to assess investigate the incidence of first attempt success rate of endotracheal intubation. Secondary objectives included assessing the predictors of first attempt success rate and the incidence and predictors of adverse events. The main question it aims to answer is whether endotracheal intubation outside the OR at AUBMC has higher success rates and lower complication rates as compared to the literature. Participants will be evaluated according to the inclusion criteria and data extraction will be performed from the electronic health record (EHR). Researchers will compare success and complication rates with previous literature and international benchmarks.

Read the detailed description

Airway management is one of the pivotal roles of anesthesiologists that extends beyond the OR to include ICUs and regular hospital floors. Managing airways outside the OR is inherently complex and challenging. Numerous guidelines for non-OR airway management exist to assist practitioners. The American University of Beirut Medical Center (AUBMC), a tertiary care facility in a lower-to-middle-income country, experienced significant variation in practices concerning non-OR airway management, similar to other institutions. Nearly a decade ago, the quality, accreditation, and risk management department partnered with the Anesthesiology and Pain Management department to implement a care bundle for airway management outside the OR, excluding the Emergency Department (ED). This multidisciplinary approach prompted an assessment of our practices, aiming to compare our success and complication rates with the literature and international benchmarks.

This is a prospective observational study to evaluate the outcomes of endotracheal intubations for critically ill patients in ICUs and on regular floors. Data were prospectively collected by the anesthesia nurse assisting in the procedure or extracted from the electronic record as appropriate.

The sample size was calculated using the estimation of a simple proportion method (https://epitools.ausvet.com.au/oneproportion). Studies have shown a first attempt success rate of 75%. Based on these results, a sample size of 100 patients was calculated, based on an estimated proportion of 70%, a desired precision of estimate of 10%, a confidence level of 95%, and an estimated dropout rate of 20%. However, to improve the power of our study and to allow for subgroup analysis, we elected to enroll 200 patients. All statistical analyses were conducted using IBM-SPSS (version 29, Armonk NY, USA).

Descriptive analysis was performed for patients' demographics and the clinical characteristics of the study participants. Means and standard deviations were computed for continuous variables, and frequencies and percentages were calculated for categorical variables. Simple logistic regression was used to study the correlation between preoperative variables with the first attempt success rate. Also, simple logistic regression was used to study the association between preoperative variables, and the development of hypotension and hypoxemia during intubation. Variables with a P value \< 0.25 were included in the multivariable logistic regression analysis. Multivariable logistic regression analysis was performed to identify the independent predictors of first attempt success rate, hypotension and hypoxemia during intubation, while adjusting for other preoperative variables. A P value \< 0.05 was considered statistically significant. Multi-collinearity between covariates was assessed using Pearson's Correlation Coefficient. All models' fits were assessed using the Hosmer and Lemeshow test and using the C statistic, which is the area under the receiver operating characteristic curve.

02

Conditions studied

  • Airway Management
  • Intensive Care Unit
03

In context

Lead sponsor

American University of Beirut Medical Center is the lead sponsor of 157 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients requiring elective or emergent endotracheal intubation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients in the ED.
  • Patients intubated by non-anesthesia providers.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
199 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. The success rate of endotracheal intubation at first attempt

    The success rate of endotracheal intubation at first attempt outside the OR

    Time frame: During endotracheal intubation

Secondary outcomes

  1. Adverse events (Hypoxemia)

    Hypoxemia (SpO2 \< 85%)

    Time frame: During the procedure

  2. Adverse events (Hypotension)

    Hypotension (SBP \< 80 mmHg)

    Time frame: During the procedure

  3. Adverse events (cardiac arrest)

    Development of cardiac arrest

    Time frame: During the procedure

  4. Total number of attempts

    Total number of attempts

    Time frame: During the procedure

  5. Time to successful intubation

    Time to successful intubation in minutes

    Time frame: During the procedure

  6. Equipment

    Type of equipments used (direct laryngoscopy/video laryngoscopy/awake fiberoptic)

    Time frame: During the procedure

  7. Medications

    Type of medications used (Rocuronium, Midazolam, Propofol, vasoactive drugs)

    Time frame: During the procedure

07

Study locations

1 site
  • AUBMC
    Beirut, Lebanon
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2021 to primary completion in Sep 2023, 30 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2021
First posted
Feb 24, 2021
StartActual
Mar 2, 2021
Primary completionActual
Sep 26, 2023
CompletionActual
Sep 26, 2023
Last update
Aug 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04769154
Responsible party
Dr. Marie Awad (Professor and Chairperson, American University of Beirut Medical Center) — Principal investigator
First posted
Feb 24, 2021
Start date
Mar 2, 2021
Primary completion
Sep 26, 2023
Completion
Sep 26, 2023
Last update
Aug 9, 2024

Study contacts

Marie Aouad-Maroun, MD
principal investigator · American University of Beirut Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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