Clinical trial NCT02508948: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheal Intubation
Keywords: airway management
critically ill
hemodynamic management
intubation
prospective study
risk factors
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Berkshire Medical Center
name: Bridgeport Hospital
name: Detroit Medical Center
name: Geisinger Clinic
name: Marshfield Clinic
name: Memorial Medical Center
name: Mercy Hospital
name: University of North Carolina
name: Johns Hopkins University
name: University of Kentucky
name: The Cleveland Clinic
name: Wake Forest University Health Sciences
name: Corpus Christi Medical Center
name: University of Oklahoma
name: Creighton University
name: University of Southern California
name: Essentia Health
First posted: 2015-07-27
Enrollment: 1288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients admitted to 20 participating medical/surgical/mixed ICUs who underwent endotracheal intubation.

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).

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

Primary outcomes:
measure: Number of participants with Hypoxemia in the 30 minutes following intubation
timeFrame: 30 minutes
measure: Number of participants with hypotension in the 30 minutes following intubation
timeFrame: 30 minutes
measure: Number of participants with unanticipated difficult airway
timeFrame: 10 minutes
Secondary outcomes:
measure: Mechanical ventilation free days in-hospital
timeFrame: 28 days or in-hospital
measure: Total days of ICU/hospital length of stay
timeFrame: 30 days or in-hospital
measure: Number of participants with vital status (dead/alive)
timeFrame: 30 days or in-hospital
measure: Number of participants with disposition to home, nursing home or long term care facility
timeFrame: 30 days or in-hospital
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic, Scottsdale
state: Arizona
city: Los Angeles
country: United States
facility: University of South California
state: California
city: Modesto
country: United States
facility: Memorial Medical Center
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital/Yale
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic, Jacksonville
state: Florida
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Pittsfield
country: United States
facility: Cynthia Callahan,Berkshire Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Corpus Christi
country: United States
facility: Corpus Christi Medical Center
state: Texas
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Arora Health Care
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Rahul Kashyap, MBBS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.