Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study

Study Overview
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Brief Summary
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In order to examine the current endotracheal intubation practice among critically ill patients, a prospective observational multicenter study of adult critically ill patients was conducted from July 2015 to January 2017 involving 20 ICUs. In this study, the primary aim was to describe, through a prospective observational multicenter study, the current intubation practice of adult critically ill patients undergoing endotracheal intubations with a focus on deriving and validating a prediction model for both immediate airway and hemodynamic complications.

Detailed Description
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Aim 1: To derive and validate a prediction model for difficult airway (three or more attempts at laryngoscopy to place an endotracheal tube and/or the need for another operator among the critically ill) [37]. Aim 2: To derive and validate a prediction model for hemodynamic compromise, i.e., post-intubation hypotension [defined as a decrease at any point in mean arterial pressure less than 65 mmHg; systolic blood pressure less than 80 mm Hg and/or a reduction in systolic blood pressure of 40% from baseline; or the initiation of, or increase in infusion dosage of, any vasopressor medication (bolus or infusion) during the 30 minute period following intubation] [38-39]. Aim3: To derive and validate a predication model for hypoxemia (decrease in pulse oximetry to oxygen saturation less than 88% during the procedure).

Official Title
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Current State of Endotracheal Intubation Among the Critically Ill and Exploring Risk Factors for Immediate Complications of Endotracheal Intubation: a Prospective, Observational Multi-center Study (HEMAIR)

Conditions
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Tracheal Intubation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age ≥ 18 years Surgical and medical intensive care unit adult patients Adult patients requiring endotracheal intubation during the time period of study Exclusion Criteria: Patient age < 18 years Endotracheal intubations performed outside the ICU (in the operating room, in and outside the hospital) are excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Hypoxemia in the 30 minutes following intubation |  | 30 minutes | 
| Number of participants with hypotension in the 30 minutes following intubation |  | 30 minutes | 
| Number of participants with unanticipated difficult airway | defined by 3 or more attempts or two operators | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation free days in-hospital |  | 28 days or in-hospital | 
| Total days of ICU/hospital length of stay |  | 30 days or in-hospital | 
| Number of participants with vital status (dead/alive) |  | 30 days or in-hospital | 
| Number of participants with disposition to home, nursing home or long term care facility |  | 30 days or in-hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway management, critically ill, hemodynamic management, intubation, prospective study, risk factors