Tracheal IntubationHEMAIRNCT02508948
Endotracheal Intubation Among the Critically Ill: HEMAIR Pilot Study
An observational study of Tracheal Intubation, run by Mayo Clinic at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Intubation
- How many people
- 1,288 participants
- Where
- 16 sitesUnited States
- Study dates
- Aug 2015to Dec 2019
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to 20 participating medical/surgical/mixed ICUs who underwent endotracheal intubation.
Who may be able to join
- Patient age ≥ 18 years
- Surgical and medical intensive care unit adult patients
- Adult patients requiring endotracheal intubation during the time period of study
Who cannot join
- Patient age < 18 years
- Endotracheal intubations performed outside the ICU (in the operating room, in and outside the hospital) are excluded
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Bridgeport Hospital/Yale
Bridgeport, Connecticut, 06610
Cleveland Clinic
Cleveland, Ohio, 44195
Corpus Christi Medical Center
Corpus Christi, Texas, 78412
Geisinger Health System
Danville, Pennsylvania, 17822
Detroit Medical Center
Detroit, Michigan, 48201
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224
University of Kentucky
Lexington, Kentucky, 40506
University of South California
Los Angeles, California, 90089
Marshfield Clinic
Marshfield, Wisconsin, 54729
Arora Health Care
Milwaukee, Wisconsin, 53204
Memorial Medical Center
Modesto, California, 95355
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Creighton University
Omaha, Nebraska, 68729
Cynthia Callahan,Berkshire Medical Center
Pittsfield, Massachusetts, 01201
Mayo Clinic, Scottsdale
Scottsdale, Arizona, 85054
Mercy Hospital
St Louis, Missouri, 63141
About this 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)
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.
Read the 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).
- Conditions
- Tracheal Intubation
- Keywords
- airway management, critically ill, hemodynamic management, intubation, prospective study, risk factors
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Hypoxemia in the 30 minutes following intubation
Measured: 30 minutes
Number of participants with hypotension in the 30 minutes following intubation
Measured: 30 minutes
Number of participants with unanticipated difficult airway
defined by 3 or more attempts or two operators
Measured: 10 minutes
Secondary outcomes (4)
Mechanical ventilation free days in-hospital
Measured: 28 days or in-hospital
Total days of ICU/hospital length of stay
Measured: 30 days or in-hospital
Number of participants with vital status (dead/alive)
Measured: 30 days or in-hospital
Number of participants with disposition to home, nursing home or long term care facility
Measured: 30 days or in-hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2017
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,288 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- 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, Wake Forest University Health Sciences, Corpus Christi Medical Center, University of Oklahoma, Creighton University, University of Southern California, Essentia Health
- Responsible party
- Principal investigator, Nathan J. Smischney, Mayo Clinic
- Investigators
- Rahul Kashyap, MBBS, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508948
- Sponsor's protocol ID
- 15-002328
- Acronym
- HEMAIR
- Status last verified
- Jan 2020
- First submitted
- 21 Jul 2015
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35243921Smischney 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.
PubMed 33000661Smischney 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.
PubMed 32866219Smischney 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.
PubMed 30530463
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02508948
- Acronym / sponsor ID
- HEMAIR / 15-002328
- Conditions
- Tracheal Intubation
- Keywords
- airway management, critically ill, hemodynamic management, intubation, prospective study, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,288 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- 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, Wake Forest University Health Sciences, Corpus Christi Medical Center, University of Oklahoma, Creighton University, University of Southern California, Essentia Health
- Study start
- Aug 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to 20 participating medical/surgical/mixed ICUs who underwent endotracheal intubation.
Key inclusion criteria (3 listed)
- Patient age ≥ 18 years
- Surgical and medical intensive care unit adult patients
- Adult patients requiring endotracheal intubation during the time period of study
Key exclusion criteria (2 listed)
- Patient age < 18 years
- Endotracheal intubations performed outside the ICU (in the operating room, in and outside the hospital) are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 35243921Smischney 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.
- Derived from this study: PubMed 33000661Smischney 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.
- Derived from this study: PubMed 32866219Smischney 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.
- Derived from this study: PubMed 30530463Smischney 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul Kashyap, MBBS study director
Mayo Clinic
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Intubation, run by Mayo Clinic at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Hypoxemia in the 30 minutes following intubation (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02508948, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.