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Postextubation Management in Patients at Risk for Extubation Failure

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. Read our disclaimer for details. Identifier: NCT04258020
Recruitment Status : Suspended (Study is on hold due to significant impact of COVID pandemic)
First Posted : February 6, 2020
Last Update Posted : October 8, 2020
Information provided by (Responsible Party):

Brief Summary:
At the time of weaning from mechanical ventilation, patients with heart and/or lung conditions will be given oxygen support with alternating bilevel positive airway pressure (BiPAP; oxygen via face mask) and heated high flow nasal cannula oxygen (HFNC; oxygen via nasal cannula) to see if this method reduces the likelihood of re-intubation.

Condition or disease Intervention/treatment Phase
Ventilatory Failure Device: BiPAP Device: HFNC Not Applicable

Detailed Description:

It is clinically challenging to predict when patients can be successfully removed from mechanical ventilation (MV). Liberating high-risk patients such as the elderly and those with complex, chronic cardiac or pulmonary diseases from MV is particularly challenging.

Evidence from randomized trials and meta-analyses suggests that the type of postextubation supportive care provided, such as oxygen delivery via nose or mouth, may affect the risk of reintubation. However, it is unclear which of many possible postextubation management protocols results in the best patient outcomes, particularly for this subset of high-risk patients.

The purpose of this study is therefore to assess a standardized combined protocol of postextubation oxygen delivery consisting of early, alternating BiPAP with HFNC over 24 hours following extubation. BiPAP and HFNC are both currently provided to patients as standard of care, based on clinician judgement; however, the timing and nature of the methods are variable.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exploratory Trial to Improve Postextubation Management for Patients at Risk for Extubation Failure
Actual Study Start Date : February 11, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : July 1, 2022

Arm Intervention/treatment
Experimental: Experimental: alternating BiPAP and HFNC
Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation
Device: BiPAP
Bilvel Positive Airway Pressure (BiPAP) oxygen administration

Device: HFNC
Heated High Flow Nasal Cannula oxygen administration

No Intervention: Historical Control: standard of care
A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.

Primary Outcome Measures :
  1. Re-intubation rate within 72 hours [ Time Frame: 72 hours following extubation ]
    The proportion of patients who require re-intubation

Secondary Outcome Measures :
  1. Re-intubation rate within 1 week [ Time Frame: 1 week following extubation ]
    The proportion of patients who require re-intubation

  2. Length of stay [ Time Frame: Through hospital discharge, an average of 14.1 ± 16.9 days ]
    Hospital length of stay

  3. Ventilator time [ Time Frame: Through hospital discharge, an average of 14.1 ± 16.9 days ]
    The total duration of time patients spend on a ventilator

  4. Mortality [ Time Frame: Through hospital discharge, an average of 14.1 ± 16.9 days ]
    The proportion of patients who expire during the hospital stay

  5. Adverse event rate [ Time Frame: Through 1 week following extubation ]
    The proportion of patients experiencing an adverse event

  6. 30-day readmission [ Time Frame: 30 days following discharge ]
    The proportion of patients who require re-admission within 30 days of discharge

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Documented high-risk factors of interest [congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and/or positive fluid balance]
  • The modified rapid shallow breathing index on day of extubation must be between 58-105 breaths per minute per liter (breaths/min/L)
  • Patient must successfully complete spontaneous breathing trial and be determined eligible for extubation
  • Only primary extubations will be included

Exclusion Criteria:

  • Undergoing terminal extubation or placed on comfort care
  • Home ventilator use
  • Any contraindication that would preclude the postextubation protocol (e.g., facial trauma, tracheotomy, or any other reason that would preclude use of BiPAP or HFNC)

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 identifier (NCT number): NCT04258020

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United States, Ohio
OhioHealth Grant Medical Center
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
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Principal Investigator: Kiran Devulapally, MD OhioHealth
  Study Documents (Full-Text)

Documents provided by OhioHealth:
Informed Consent Form  [PDF] November 4, 2019

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Responsible Party: OhioHealth Identifier: NCT04258020    
Other Study ID Numbers: 1332767
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory