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Completed

NCT Number: NCT02508948

Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Scottsdale, Scottsdale, Arizona, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants with Hypoxemia in the 30 minutes following intubation

    Time frame: 30 minutes

  2. Number of participants with hypotension in the 30 minutes following intubation

    Time frame: 30 minutes

  3. Number of participants with unanticipated difficult airway

    Time frame: 10 minutes

    defined by 3 or more attempts or two operators

Secondary outcomes

  1. Mechanical ventilation free days in-hospital

    Time frame: 28 days or in-hospital

  2. Total days of ICU/hospital length of stay

    Time frame: 30 days or in-hospital

  3. Number of participants with vital status (dead/alive)

    Time frame: 30 days or in-hospital

  4. Number of participants with disposition to home, nursing home or long term care facility

    Time frame: 30 days or in-hospital

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • 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
  • Wake Forest University Health Sciences

Registry information

Official study 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)

Acronym: HEMAIR

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Jul 27, 2015
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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