Postextubation Management in Patients at Risk for Extubation Failure
Primary Purpose
Ventilatory Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BiPAP
HFNC
Sponsored by
About this trial
This is an interventional supportive care trial for Ventilatory Failure
Eligibility Criteria
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)
Sites / Locations
- OhioHealth Grant Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: alternating BiPAP and HFNC
Historical Control: standard of care
Arm Description
Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation
A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
Outcomes
Primary Outcome Measures
Re-intubation Within 72 Hours
The number of patients who require re-intubation
Secondary Outcome Measures
Re-intubation Within 1 Week
The number of patients who require re-intubation
Length of Stay
Hospital length of stay
Ventilator Time
The total duration of time patients spend on a ventilator
Mortality
The proportion of patients who expire during the hospital stay
Adverse Event Rate
The proportion of patients experiencing an adverse event
30-day Readmission
The proportion of patients who require re-admission within 30 days of discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04258020
Brief Title
Postextubation Management in Patients at Risk for Extubation Failure
Official Title
Exploratory Trial to Improve Postextubation Management for Patients at Risk for Extubation Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Significant impact of COVID pandemic on ability to conduct study
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
April 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OhioHealth
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilatory Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: alternating BiPAP and HFNC
Arm Type
Experimental
Arm Description
Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation
Arm Title
Historical Control: standard of care
Arm Type
No Intervention
Arm Description
A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.
Intervention Type
Device
Intervention Name(s)
BiPAP
Intervention Description
Bilevel Positive Airway Pressure (BiPAP) oxygen administration
Intervention Type
Device
Intervention Name(s)
HFNC
Intervention Description
Heated High Flow Nasal Cannula oxygen administration
Primary Outcome Measure Information:
Title
Re-intubation Within 72 Hours
Description
The number of patients who require re-intubation
Time Frame
72 hours following extubation
Secondary Outcome Measure Information:
Title
Re-intubation Within 1 Week
Description
The number of patients who require re-intubation
Time Frame
1 week following extubation
Title
Length of Stay
Description
Hospital length of stay
Time Frame
Through hospital discharge, an average of 10.9 ± 1.91 days
Title
Ventilator Time
Description
The total duration of time patients spend on a ventilator
Time Frame
Through hospital discharge, an average of 10.9 ± 1.91 days
Title
Mortality
Description
The proportion of patients who expire during the hospital stay
Time Frame
Through hospital discharge, an average of 10.9 ± 1.91 days
Title
Adverse Event Rate
Description
The proportion of patients experiencing an adverse event
Time Frame
Through 1 week following extubation
Title
30-day Readmission
Description
The proportion of patients who require re-admission within 30 days of discharge
Time Frame
30 days following discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiran Devulapally, MD
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
OhioHealth Grant Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Postextubation Management in Patients at Risk for Extubation Failure
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