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

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ClinicalTrials.gov Identifier: NCT02508948
Recruitment Status : Completed
First Posted : July 27, 2015
Last Update Posted : January 30, 2020
Sponsor:
Collaborators:
Berkshire Medical Center
Bridgeport Hospital
Detroit Medical Center
Geisinger Clinic
Marshfield Clinic
Memorial Medical Center
Mercy Hospital
University of North Carolina
Johns Hopkins University
University of Kentucky
The Cleveland Clinic
Aurora Health Care
Corpus Christi Medical Center
University of Oklahoma
Creighton University
University of Southern California
Essentia Health
Information provided by (Responsible Party):
Nathan J. Smischney, Mayo Clinic

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.

Condition or disease
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).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1288 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official 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)
Study Start Date : August 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2019



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients admitted to 20 participating medical/surgical/mixed ICUs who underwent endotracheal intubation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508948


Locations
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United States, Arizona
Mayo Clinic, Scottsdale
Scottsdale, Arizona, United States, 85054
United States, California
University of South California
Los Angeles, California, United States, 90089
Memorial Medical Center
Modesto, California, United States, 95355
United States, Connecticut
Bridgeport Hospital/Yale
Bridgeport, Connecticut, United States, 06610
United States, Florida
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States, 32224
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
United States, Massachusetts
Cynthia Callahan,Berkshire Medical Center
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Detroit Medical Center
Detroit, Michigan, United States, 48201
United States, Missouri
Mercy Hospital
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68729
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17822
United States, Texas
Corpus Christi Medical Center
Corpus Christi, Texas, United States, 78412
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54729
Arora Health Care
Milwaukee, Wisconsin, United States, 53204
Sponsors and Collaborators
Mayo Clinic
Berkshire Medical Center
Bridgeport Hospital
Detroit Medical Center
Geisinger Clinic
Marshfield Clinic
Memorial Medical Center
Mercy Hospital
University of North Carolina
Johns Hopkins University
University of Kentucky
The Cleveland Clinic
Aurora Health Care
Corpus Christi Medical Center
University of Oklahoma
Creighton University
University of Southern California
Essentia Health
Investigators
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Study Director: Rahul Kashyap, MBBS Mayo Clinic
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nathan J. Smischney, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02508948    
Other Study ID Numbers: 15-002328
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nathan J. Smischney, Mayo Clinic:
airway management
critically ill
hemodynamic management
intubation
prospective study
risk factors
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes