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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02508948
Acronym
HEMAIR
Enrollment
1288
Registered
2015-07-27
Start date
2015-08-31
Completion date
2019-12-31
Last updated
2020-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheal Intubation

Keywords

airway management, critically ill, hemodynamic management, intubation, prospective study, risk factors

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).

Interventions

None listed

Sponsors

Berkshire Medical Center
CollaboratorOTHER
Bridgeport Hospital
CollaboratorOTHER
Detroit Medical Center
CollaboratorOTHER
Geisinger Clinic
CollaboratorOTHER
Marshfield Clinic
CollaboratorUNKNOWN
Memorial Medical Center
CollaboratorOTHER
Mercy Hospital
CollaboratorUNKNOWN
University of North Carolina
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
University of Kentucky
CollaboratorOTHER
The Cleveland Clinic
CollaboratorOTHER
Wake Forest University Health Sciences
CollaboratorOTHER
Corpus Christi Medical Center
CollaboratorUNKNOWN
University of Oklahoma
CollaboratorOTHER
Creighton University
CollaboratorOTHER
University of Southern California
CollaboratorOTHER
Essentia Health
CollaboratorOTHER
Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with Hypoxemia in the 30 minutes following intubation30 minutes
Number of participants with hypotension in the 30 minutes following intubation30 minutes
Number of participants with unanticipated difficult airway10 minutesdefined by 3 or more attempts or two operators

Secondary

MeasureTime frame
Mechanical ventilation free days in-hospital28 days or in-hospital
Number of participants with disposition to home, nursing home or long term care facility30 days or in-hospital
Total days of ICU/hospital length of stay30 days or in-hospital
Number of participants with vital status (dead/alive)30 days or in-hospital

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026