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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tracheal Intubation
- Sponsor
- Mayo Clinic
- Enrollment
- 1288
- Locations
- 16
- Primary Endpoint
- Number of participants with Hypoxemia in the 30 minutes following intubation
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Nathan J. Smischney
PI
Mayo Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of participants with Hypoxemia in the 30 minutes following intubation
Time Frame: 30 minutes
Number of participants with hypotension in the 30 minutes following intubation
Time Frame: 30 minutes
Number of participants with unanticipated difficult airway
Time Frame: 10 minutes
defined by 3 or more attempts or two operators
Secondary Outcomes
- 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)