Trials / Completed
CompletedNCT02508948
Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study
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)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,288 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2017-12-01
- Completion
- 2019-12-01
- First posted
- 2015-07-27
- Last updated
- 2020-01-30
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02508948. Inclusion in this directory is not an endorsement.