Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study

Tracheal Intubation Clinical Trial

— HEMAIR  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508948
• Other study ID #: 15-002328
• Status: Completed
• Start date: August 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1288
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Tracheal Intubation

Locations

Country	Name	City	State
United States	Bridgeport Hospital/Yale	Bridgeport	Connecticut
United States	Cleveland Clinic	Cleveland	Ohio
United States	Corpus Christi Medical Center	Corpus Christi	Texas
United States	Geisinger Health System	Danville	Pennsylvania
United States	Detroit Medical Center	Detroit	Michigan
United States	Mayo Clinic, Jacksonville	Jacksonville	Florida
United States	University of Kentucky	Lexington	Kentucky
United States	University of South California	Los Angeles	California
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Arora Health Care	Milwaukee	Wisconsin
United States	Memorial Medical Center	Modesto	California
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Creighton University	Omaha	Nebraska
United States	Cynthia Callahan,Berkshire Medical Center	Pittsfield	Massachusetts
United States	Mercy Hospital	Saint Louis	Missouri
United States	Mayo Clinic, Scottsdale	Scottsdale	Arizona

Sponsors (18)

Lead Sponsor	Collaborator
Mayo Clinic	Aurora Health Care, Berkshire Medical Center, Bridgeport Hospital, Corpus Christi Medical Center, Creighton University, Detroit Medical Center, Essentia Health, Geisinger Clinic, Johns Hopkins University, Marshfield Clinic, Memorial Medical Center, Mercy Hospital, The Cleveland Clinic, University of Kentucky, University of North Carolina, University of Oklahoma, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Hypoxemia in the 30 minutes following intubation		30 minutes
Primary	Number of participants with hypotension in the 30 minutes following intubation		30 minutes
Primary	Number of participants with unanticipated difficult airway	defined by 3 or more attempts or two operators	10 minutes
Secondary	Mechanical ventilation free days in-hospital		28 days or in-hospital
Secondary	Total days of ICU/hospital length of stay		30 days or in-hospital
Secondary	Number of participants with vital status (dead/alive)		30 days or in-hospital
Secondary	Number of participants with disposition to home, nursing home or long term care facility		30 days or in-hospital

External Links

•   Mayo Clinic Clinical Trials