Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1288
- Patient age ≥ 18 years
- Surgical and medical intensive care unit adult patients
- Adult patients requiring endotracheal intubation during the time period of study
- 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 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
Trial Locations
- Locations (16)
Detroit Medical Center
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Geisinger Health System
🇺🇸Danville, Pennsylvania, United States
Corpus Christi Medical Center
🇺🇸Corpus Christi, Texas, United States
University of South California
🇺🇸Los Angeles, California, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Creighton University
🇺🇸Omaha, Nebraska, United States
Mayo Clinic, Scottsdale
🇺🇸Scottsdale, Arizona, United States
Memorial Medical Center
🇺🇸Modesto, California, United States
Mercy Hospital
🇺🇸Saint Louis, Missouri, United States
Cynthia Callahan,Berkshire Medical Center
🇺🇸Pittsfield, Massachusetts, United States
Mayo Clinic, Jacksonville
🇺🇸Jacksonville, Florida, United States
Bridgeport Hospital/Yale
🇺🇸Bridgeport, Connecticut, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Arora Health Care
🇺🇸Milwaukee, Wisconsin, United States