Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study

NCT ID: NCT02508948

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Tracheal Intubation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Berkshire Medical Center

OTHER

Sponsor Role collaborator

Bridgeport Hospital

OTHER

Sponsor Role collaborator

Detroit Medical Center

OTHER

Sponsor Role collaborator

Geisinger Clinic

OTHER

Sponsor Role collaborator

Marshfield Clinic

UNKNOWN

Sponsor Role collaborator

Memorial Medical Center

OTHER

Sponsor Role collaborator

Mercy Hospital

UNKNOWN

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

Corpus Christi Medical Center

UNKNOWN

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role collaborator

Essentia Health

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Nathan J. Smischney

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rahul Kashyap, MBBS

Role: STUDY_DIRECTOR

Mayo Clinic

Locations

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Mayo Clinic, Scottsdale

Scottsdale, Arizona, United States

Site Status

University of South California

Los Angeles, California, United States

Site Status

Memorial Medical Center

Modesto, California, United States

Site Status

Bridgeport Hospital/Yale

Bridgeport, Connecticut, United States

Site Status

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Cynthia Callahan,Berkshire Medical Center

Pittsfield, Massachusetts, United States

Site Status

Detroit Medical Center

Detroit, Michigan, United States

Site Status

Mercy Hospital

St Louis, Missouri, United States

Site Status

Creighton University

Omaha, Nebraska, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Geisinger Health System

Danville, Pennsylvania, United States

Site Status

Corpus Christi Medical Center

Corpus Christi, Texas, United States

Site Status

Marshfield Clinic

Marshfield, Wisconsin, United States

Site Status

Arora Health Care

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35243921 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33000661 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32866219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30530463 (View on PubMed)

Related Links

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Other Identifiers

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15-002328

Identifier Type: -

Identifier Source: org_study_id

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