Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study (HEMAIR)

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)

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.

Study Overview

• Status: Completed
• Conditions: Tracheal Intubation

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).

• Study Type: Observational
• Enrollment (Actual): 1288

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85054
      • Mayo Clinic, Scottsdale
  • California
    • Los Angeles, California, United States, 90089
      • University of South California
    • Modesto, California, United States, 95355
      • Memorial Medical Center
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital/Yale
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic, Jacksonville
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University Of Kentucky
  • Massachusetts
    • Pittsfield, Massachusetts, United States, 01201
      • Cynthia Callahan,Berkshire Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Detroit Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68729
      • Creighton University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health System
  • Texas
    • Corpus Christi, Texas, United States, 78412
      • Corpus Christi Medical Center
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54729
      • Marshfield Clinic
    • Milwaukee, Wisconsin, United States, 53204
      • Arora Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients admitted to 20 participating medical/surgical/mixed ICUs who underwent endotracheal intubation.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Hypoxemia in the 30 minutes following intubation		30 minutes
Number of participants with hypotension in the 30 minutes following intubation		30 minutes
Number of participants with unanticipated difficult airway	defined by 3 or more attempts or two operators	10 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Johns Hopkins University; University of Oklahoma; The Cleveland Clinic; University of Southern California; Creighton University; University of Kentucky; Aurora Health Care; Geisinger Clinic; University of North Carolina; Essentia Health; Memorial Medical Center; Bridgeport Hospital; Detroit Medical Center; Berkshire Medical Center; Marshfield Clinic; Mercy Hospital; Corpus Christi Medical Center
• Investigators: Study Director: Rahul Kashyap, MBBS, Mayo Clinic

Publications and helpful links

General Publications

• Smischney NJ, Surani SR, Montgomery A, Franco PM, Callahan C, Demiralp G, Tedja R, Lee S, Kumar SI, Khanna AK. Hypotension Prediction Score for Endotracheal Intubation in Critically Ill Patients: A Post Hoc Analysis of the HEMAIR Study. J Intensive Care Med. 2022 Nov;37(11):1467-1479. doi: 10.1177/08850666221085256. Epub 2022 Mar 4.
• Smischney NJ, Khanna AK, Brauer E, Morrow LE, Ofoma UR, Kaufman DA, Sen A, Venkata C, Morris P, Bansal V. Risk Factors for and Outcomes Associated With Peri-Intubation Hypoxemia: A Multicenter Prospective Cohort Study. J Intensive Care Med. 2021 Dec;36(12):1466-1474. doi: 10.1177/0885066620962445. Epub 2020 Oct 1.
• Smischney NJ, Kashyap R, Khanna AK, Brauer E, Morrow LE, Seisa MO, Schroeder DR, Diedrich DA, Montgomery A, Franco PM, Ofoma UR, Kaufman DA, Sen A, Callahan C, Venkata C, Demiralp G, Tedja R, Lee S, Geube M, Kumar SI, Morris P, Bansal V, Surani S; SCCM Discovery (Critical Care Research Network of Critical Care Medicine) HEMAIR Investigators Consortium. Risk factors for and prediction of post-intubation hypotension in critically ill adults: A multicenter prospective cohort study. PLoS One. 2020 Aug 31;15(8):e0233852. doi: 10.1371/journal.pone.0233852. eCollection 2020.
• Smischney N, Kashyap R, Seisa M, Schroeder D, Diedrich D. Endotracheal Intubation Among the Critically Ill: Protocol for a Multicenter, Observational, Prospective Study. JMIR Res Protoc. 2018 Dec 7;7(12):e11101. doi: 10.2196/11101.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimate): July 27, 2015

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: risk factors; critically ill; airway management; intubation; prospective study; hemodynamic management
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 15-002328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO