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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,288

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach

1 country

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

First Submitted

Initial submission to the registry

July 21, 2015

Completed

6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed

5 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed

Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

2.3 years

First QC Date

July 21, 2015

Last Update Submit

January 28, 2020

Conditions

Tracheal Intubation

Keywords

airway managementcritically illhemodynamic managementintubationprospective studyrisk factors

Outcome Measures

Primary Outcomes (3)

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 Outcomes (4)

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

Patient age ≥ 18 years
Surgical and medical intensive care unit adult patients
Adult patients requiring endotracheal intubation during the time period of study

You may not qualify if:

Patient age \< 18 years
Endotracheal intubations performed outside the ICU (in the operating room, in and outside the hospital) are excluded

Contact the study team to confirm eligibility.

Study Sites (16)

Mayo Clinic, Scottsdale

Scottsdale, Arizona, 85054, United States

Location

University of South California

Los Angeles, California, 90089, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Bridgeport Hospital/Yale

Bridgeport, Connecticut, 06610, United States

Location

Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Cynthia Callahan,Berkshire Medical Center

Pittsfield, Massachusetts, 01201, United States

Location

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Mercy Hospital

St Louis, Missouri, 63141, United States

Location

Creighton University

Omaha, Nebraska, 68729, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Corpus Christi Medical Center

Corpus Christi, Texas, 78412, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54729, United States

Location

Arora Health Care

Milwaukee, Wisconsin, 53204, United States

Location

Related Publications (4)

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.
PMID: 35243921DERIVED
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.
PMID: 33000661DERIVED
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.
PMID: 32866219DERIVED
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.
PMID: 30530463DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Rahul Kashyap, MBBS
Mayo Clinic
STUDY DIRECTOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 28 Days
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: PI

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 27, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing: Will not share

Locations

US(16)

Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (16)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (16)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations