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Completed

NCT Number: NCT04769154

Adult Airway Management in the Intensive Care Units and Regular Floors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AUBMC

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Secondary outcomes

  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)

  3. Adverse events (cardiac arrest)

    Time frame: During the procedure

    Development of cardiac arrest

  4. Total number of attempts

    Time frame: During the procedure

    Total number of attempts

  5. Time to successful intubation

    Time frame: During the procedure

    Time to successful intubation in minutes

  6. Equipment

    Time frame: During the procedure

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

  7. Medications

    Time frame: During the procedure

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

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

Adult Airway Management in The Intensive Care Units and Regular Floors: A Prospective Observational Study in A Tertiary Care Center

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2021
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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