Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
NCT ID: NCT05918575
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2023-07-10
2026-12-01
Brief Summary
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Detailed Description
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The purpose of this RCT will be to determine the effects of using NIV alternating with HFNC for reducing the treatment failure rate compared with HFNC alone in extubated patients with severe obesity. We hypothesize that early, prophylactic use of NIV alternating with HFNC will decrease the risk of respiratory failure (treatment failure) in severely obese patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention Group (NIV with HFNC)
Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation
Noninvasive ventilation alternating with high flow nasal cannula
A total of 24 hours of prophylactic respiratory support will be provided using NIV alternating with HFNC with total NIV usage of 16 hours and HFNC usage of 8 hours.
Control Group (HFNC alone)
Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation
High flow nasal cannula
A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.
Interventions
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Noninvasive ventilation alternating with high flow nasal cannula
A total of 24 hours of prophylactic respiratory support will be provided using NIV alternating with HFNC with total NIV usage of 16 hours and HFNC usage of 8 hours.
High flow nasal cannula
A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.
Eligibility Criteria
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Inclusion Criteria
2. Receiving invasive mechanical ventilation for ≥24 hours
3. BMI ≥40 kg/m2
4. Undergoing planned extubation per treating team
5. Arterial pH ≥7.35 or venous pH ≥ 7.31 within 30 mins of spontaneous breathing trial (SBT)
Exclusion Criteria
2. Use of extra-corporeal membrane oxygenation
3. Chronic tracheostomy in place
4. Unplanned or accidental extubation
5. Terminal/compassionate extubation
6. Contraindication to NIV use
7. Intubated because of an acute exacerbation of COPD
8. Underlying neuromuscular disease
9. No reintubation requested by patient/family
10. Documented/known history of chronic hypercapnic respiratory failure on home NIV (including bilevel PAP).
11. Enrolled in any other outcome study
12. Treating clinician feels that HFNC or NIV are either mandatory or contraindicated for a given patient
18 Years
ALL
No
Sponsors
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Hospital Civil de Guadalajara
OTHER
Medical College of Wisconsin
OTHER
The University of Texas Health Science Center, Houston
OTHER
Central DuPage Hospital
OTHER
Rush University Medical Center
OTHER
Responsible Party
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Ramandeep Kaur
Principal Investigator
Principal Investigators
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Ramandeep Kaur, PhD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Babak Mokhlesi, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Central DuPage Hospital
Winfield, Illinois, United States
McGovern Medical School, The University of Texas Health Science Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23050803
Identifier Type: -
Identifier Source: org_study_id
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