Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study

Completed

• Conditions: Tracheal Intubation

• Registration Number: NCT02508948
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-27
• Study Start: 2015-08
• Primary Completion: 2017-12
• Study Completion: 2019-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1288

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	10 minutes	defined by 3 or more attempts or two operators

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation free days in-hospital	28 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
Total days of ICU/hospital length of stay	30 days or in-hospital

Trial Locations

Locations (16)

Mayo Clinic, Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

University of South California; 🇺🇸 Los Angeles, California, United States

Memorial Medical Center; 🇺🇸 Modesto, California, United States

Bridgeport Hospital/Yale; 🇺🇸 Bridgeport, Connecticut, United States

Mayo Clinic, Jacksonville; 🇺🇸 Jacksonville, Florida, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Cynthia Callahan,Berkshire Medical Center; 🇺🇸 Pittsfield, Massachusetts, United States

Detroit Medical Center; 🇺🇸 Detroit, Michigan, United States

Mercy Hospital; 🇺🇸 Saint Louis, Missouri, United States

Creighton University; 🇺🇸 Omaha, Nebraska, United States

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