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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

Tracking Information
First Submitted Date July 21, 2015
First Posted Date July 27, 2015
Last Update Posted Date January 30, 2020
Study Start Date August 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2018)
  • Number of participants with Hypoxemia in the 30 minutes following intubation [ Time Frame: 30 minutes ]
  • Number of participants with hypotension in the 30 minutes following intubation [ Time Frame: 30 minutes ]
  • Number of participants with unanticipated difficult airway [ Time Frame: 10 minutes ]
    defined by 3 or more attempts or two operators
Original Primary Outcome Measures
 (submitted: July 23, 2015)
  • Number of participants with Hypoxemia with in 30 minutes from intubation [ Time Frame: 30 minutes ]
  • Number of participants with hypotension with in 30 minutes from intubation [ Time Frame: 30 minutes ]
Change History
Current Secondary Outcome Measures
 (submitted: December 19, 2018)
  • Mechanical ventilation free days in-hospital [ Time Frame: 28 days or in-hospital ]
  • Total days of ICU/hospital length of stay [ Time Frame: 30 days or in-hospital ]
  • Number of participants with vital status (dead/alive) [ Time Frame: 30 days or in-hospital ]
  • Number of participants with disposition to home, nursing home or long term care facility [ Time Frame: 30 days or in-hospital ]
Original Secondary Outcome Measures
 (submitted: July 23, 2015)
  • Total days on mechanical ventilation during 30 days [ Time Frame: 30 days ]
  • Total days of ICU/hospital length of stay [ Time Frame: 30 days ]
  • Number of participants with vital status (dead/alive) [ Time Frame: 30 days ]
  • Number of participants with disposition to home, nursing home or long term care facility [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study
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)
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 28 Days
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients admitted to 20 participating medical/surgical/mixed ICUs who underwent endotracheal intubation.
Condition Tracheal Intubation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 19, 2018)
1288
Original Estimated Enrollment
 (submitted: July 23, 2015)
2500
Actual Study Completion Date December 2019
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02508948
Other Study ID Numbers 15-002328
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nathan J. Smischney, Mayo Clinic
Study Sponsor Mayo Clinic
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
Investigators
Study Director: Rahul Kashyap, MBBS Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2020