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Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Primary Purpose

Obesity, Morbid, Extubation Failure

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Noninvasive ventilation alternating with high flow nasal cannula
High flow nasal cannula
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Morbid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult, age ≥ 18 years old Receiving invasive mechanical ventilation for ≥24 hours BMI ≥40 kg/m2 Undergoing planned extubation per treating team Arterial pH ≥7.35 or venous pH ≥ 7.31 within 30 mins of spontaneous breathing trial (SBT) Exclusion Criteria: Pregnant Use of extra-corporeal membrane oxygenation Chronic tracheostomy in place Unplanned or accidental extubation Terminal/compassionate extubation Contraindication to NIV use Intubated for neurological reasons or for airway protection (stroke, intracerebral hemorrhage, intraventricular hemorrhage) Intubated because of an acute exacerbation of COPD Underlying neuromuscular disease No reintubation requested by patient/family Documented/known history of chronic hypercapnic respiratory failure on home NIV (including bilevel PAP). Enrolled in any other outcome study Treating clinician feels that HFNC or NIV are either mandatory or contraindicated for a given patient

Sites / Locations

  • Rush University Medical CenterRecruiting
  • Hospital Civil Fray Antonio AlcaldeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group (NIV with HFNC)

Control Group (HFNC alone)

Arm Description

Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation

Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation

Outcomes

Primary Outcome Measures

Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation
Rescue respiratory support is defined as reintubation, use of rescue NIV or HFNC use

Secondary Outcome Measures

Reintubation rate
Need for invasive mechanical ventilation within 7 days of extubation

Full Information

First Posted
June 15, 2023
Last Updated
October 6, 2023
Sponsor
Rush University Medical Center
Collaborators
Hospital Civil de Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT05918575
Brief Title
Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
Official Title
A Randomized Controlled Trial of Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
Hospital Civil de Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Around 20% of the obese patients with higher body mass index (BMI) who are taken off the breathing tube and breathing machine (ventilator) end up needing it back to support breathing. The re-application of breathing tube is associated with poor outcomes, including high risk of pneumonia, longer hospital stays, and death. The purpose of this study is to assess if prophylactic use of noninvasive breathing support after removing the breathing tube lowers the chance of needing the breathing tube again.
Detailed Description
Patients with obesity are at risk of developing respiratory failure due to reduced lung volumes and chest wall compliance. Obesity is one of the easily identifiable, contributing factors of extubation failure that often leads to prolonged mechanical ventilation use and ICU stay. The early application of noninvasive respiratory support, especially NIV, has been shown to reduce reintubation rates in obese patients in a small, non-randomized study. However, prolonged use of NIV is often associated with decreased patient compliance and increased incidence of skin breakdown. HFNC is a noninvasive strategy that is comfortable, uses a nasal cannula and provides a high flow rate to meet the patient's inspiratory flow demand and thereby reduce work of breathing. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Extubation Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group (NIV with HFNC)
Arm Type
Experimental
Arm Description
Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation
Arm Title
Control Group (HFNC alone)
Arm Type
Active Comparator
Arm Description
Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation
Intervention Type
Device
Intervention Name(s)
Noninvasive ventilation alternating with high flow nasal cannula
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Intervention Description
A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.
Primary Outcome Measure Information:
Title
Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation
Description
Rescue respiratory support is defined as reintubation, use of rescue NIV or HFNC use
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Reintubation rate
Description
Need for invasive mechanical ventilation within 7 days of extubation
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult, age ≥ 18 years old Receiving invasive mechanical ventilation for ≥24 hours BMI ≥40 kg/m2 Undergoing planned extubation per treating team Arterial pH ≥7.35 or venous pH ≥ 7.31 within 30 mins of spontaneous breathing trial (SBT) Exclusion Criteria: Pregnant Use of extra-corporeal membrane oxygenation Chronic tracheostomy in place Unplanned or accidental extubation Terminal/compassionate extubation Contraindication to NIV use Intubated for neurological reasons or for airway protection (stroke, intracerebral hemorrhage, intraventricular hemorrhage) Intubated because of an acute exacerbation of COPD Underlying neuromuscular disease No reintubation requested by patient/family Documented/known history of chronic hypercapnic respiratory failure on home NIV (including bilevel PAP). Enrolled in any other outcome study Treating clinician feels that HFNC or NIV are either mandatory or contraindicated for a given patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramandeep Kaur, PhD
Phone
3129478898
Email
ramandeep_kaur@rush.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Babak Mokhlesi, MD
Phone
(312) 563-0843
Email
babak_mokhlesi@rush.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramandeep Kaur, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Babak Mokhlesi, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramandeep Kaur, PhD
Email
ramandeep_kaur@rush.edu
First Name & Middle Initial & Last Name & Degree
Babak Mokhlesi, MD
Email
babak_mokhlesi@rush.edu
First Name & Middle Initial & Last Name & Degree
Ramandeep Kaur, PhD
First Name & Middle Initial & Last Name & Degree
Babak Mokhlesi, MD
Facility Name
Hospital Civil Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Ángel Ibarra Estrada
Email
drmiguelibarra@hotmail.com
First Name & Middle Initial & Last Name & Degree
Miguel Ángel Ibarra Estrada, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

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