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Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04782817
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : March 24, 2023
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert Freundlich, Vanderbilt University Medical Center

Study Description
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Brief Summary:
The purpose of this study is to compare reintubation rates and outcomes of patients treated with high-flow nasal canula oxygen therapy (HFNC) and patients treated with provider choice of standard care.

Condition or disease Intervention/treatment Phase
Intubation Cardiovascular Surgical Procedure Other: Recommendation for high flow nasal cannula oxygen therapy order set Other: Provider choice standard care order set Not Applicable

Detailed Description:

HFNC may be employed as a strategy to facilitate early extubation and prevent reintubation of patients following cardiac surgery. HFNC is routinely employed by providers in the cardiovascular intensive care unit and is selectively employed in patients who are judged by the provider to be high-risk, along with other therapies: bi-level positive airway pressure, non-rebreather masks, among others. Currently, no high-quality clinical data exist to demonstrate that HFNC may decrease the risk of reintubation in this critically-ill adult population.

To guide a future, larger, multicenter randomized controlled pragmatic clinical trial, a pilot study in a single, high-volume cardiovascular intensive care unit will be performed. The prospective, randomized, pragmatic pilot clinical trial will compare HFNC to provider choice of standard care in these high-risk patients.

Randomization will occur at the time that the patient is deemed ready for extubation by the attending physician in the cardiovascular intensive care unit. Through randomization, patients will be assigned one of two physician order sets in the electronic medical record system: standard order set with or without recommendation for the use of HFNC. Reintubation and outcome data will be collected until patient discharge.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High Flow Nasal Canula Oxygen Therapy
Participants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates.
 Other: Recommendation for high flow nasal cannula oxygen therapy order set
Participants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates.
Active Comparator: Provider Choice Standard Care
Participants be assigned standard provider choice of standard care therapy physician order set.
 Other: Provider choice standard care order set
Participants will receive order set with provider choice of standard care therapy.


Outcome Measures
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Primary Outcome Measures :
  1. Reintubation within 48 hours of extubation [ Time Frame: 48 hours ]
    Reintubation within 48 hours of initial extubation after cardiac surgery


Secondary Outcome Measures :
  1. Reintubation within 72 hours of extubation [ Time Frame: 72 hours ]
    Reintubation within 72 hours of initial extubation after cardiac surgery

  2. Reintubation after cardiac surgery [ Time Frame: hospital discharge (usually 14 days) ]
    Reintubation at any time during hospitalization after cardiac surgery

  3. In-hospital mortality [ Time Frame: hospital discharge (usually 14 days) ]
    In-hospital mortality during hospitalization after cardiac surgery

  4. All cause mortality [ Time Frame: 30 days post surgery ]
  5. Hospital length of stay [ Time Frame: 8 days ]
  6. Intensive Care Unit length of stay [ Time Frame: 3 days ]
    Intensive Care Unit length of stay after cardiac surgery

  7. Ventilator-free days [ Time Frame: 1 day ]
    Ventilator-free days during hospitalization after cardiac surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18 and over treated in the Vanderbilt Cardiovascular Intensive Care Unit following cardiac surgery (defined as surgery on the heart or thoracic aorta, excluding percutaneous procedures)
  • Surgical duration (anesthesia start to anesthesia stop) of at least 3 hours.
  • Intubated at the time of arrival in the Cardiovascular Intensive Care Unit
  • Extubated to occur at some point following arrival in the Cardiovascular Intensive Care Unit with an order to extubate the patient by a treating provider.

Exclusion Criteria:

  • Does not meet inclusion criteria
Contacts and Locations
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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): NCT04782817


Contacts
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Contact: Robert E Freundlich, MD (615)936-6608 robert.e.freundlich@vumc.org
Contact: Gail Mayo (615)936-1705 gail.mayo@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Robert E Freundlich, MD    615-936-6608    robert.e.freundlich@vumc.org   
Contact: Gail Mayo, RN    (615)936-1705    gail.mayo@vumc.org   
Sponsors and Collaborators
Vanderbilt University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Robert E Freundlich, MD Vanderbilt University Medical Center
More Information
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Publications:

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Responsible Party: Robert Freundlich, Assistant Professor of Anesthesiology and Biomedical Informatics, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04782817    
Other Study ID Numbers: 181117
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Freundlich, Vanderbilt University Medical Center:
High-flow nasal cannula oxygen therapy
Reintubation