Obesity, MorbidNCT05918575
Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
A study testing Noninvasive ventilation alternating with high flow nasal cannula and High flow nasal cannula in people with Obesity, Morbid and Extubation Failure, run by Rush University Medical Center at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid, Extubation Failure
- What is being tested?
- Noninvasive ventilation alternating with high flow nasal cannula and High flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 10 Jul 2023to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Pregnant
- Use of extra-corporeal membrane oxygenation
- Chronic tracheostomy in place
- Unplanned or accidental extubation
- Terminal/compassionate extubation
- Contraindication to NIV use
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Ramandeep Kaur, PhD, ramandeep_kaur@rush.edu
Babak Mokhlesi, MD, babak_mokhlesi@rush.edu
- Recruiting
McGovern Medical School, The University of Texas Health Science Center
Houston, Texas, 77030
Rosa M. Estrada-Y-Martin, MD, rosa.m.estrada.y.martin@uth.tmc.edu
Rosa M. Estrada-Y-Martin, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Rahul Nanchal, MD, rnanchal@mcw.edu
Rahul Nanchal, MD
- Not yet recruiting
Central DuPage Hospital
Winfield, Illinois, 60190
Ankeet Patel, Ankeet.Patel@nm.org
Ankeet Patel
Mexico1 site, 1 recruiting
- Recruiting
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
Miguel Ángel Ibarra Estrada, drmiguelibarra@hotmail.com
Miguel Ángel Ibarra Estrada, MD
About this study
Official title: A Randomized Controlled Trial of Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
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.
Read the 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.
- Conditions
- Obesity, Morbid, Extubation Failure
- Being tested
- Noninvasive ventilation alternating with high flow nasal cannula, High flow nasal cannula
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive ventilation alternating with high flow nasal cannulaDevice
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 cannulaDevice
A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (NIV with HFNC) | Experimental | Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation Receives: Device: Noninvasive ventilation alternating with high flow nasal cannula |
| Control Group (HFNC alone) | Active comparator | Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation Receives: Device: High flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Secondary outcomes (1)
Reintubation rate
Need for invasive mechanical ventilation within 7 days of extubation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start10 Jul 2023
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Civil de Guadalajara, Medical College of Wisconsin, The University of Texas Health Science Center, Houston, Central DuPage Hospital
- Responsible party
- Principal investigator, Ramandeep Kaur, Rush University Medical Center
- Investigators
- Ramandeep Kaur, PhD, Principal investigator, Rush University Medical CenterBabak Mokhlesi, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918575
- Sponsor's protocol ID
- 23050803
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
- ClinicalTrials.gov ID
- NCT05918575
- Acronym / sponsor ID
- 23050803
- Conditions
- Obesity, Morbid, Extubation Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Hospital Civil de Guadalajara, Medical College of Wisconsin, The University of Texas Health Science Center, Houston, Central DuPage Hospital
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (NIV with HFNC) | Experimental | Device: Noninvasive ventilation alternating with high flow nasal cannulaPatients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation |
| Control Group (HFNC alone) | Active comparator | Device: High flow nasal cannulaPatients randomized to the intervention group will receive HFNC only for 24 hours after extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- Pregnant
- Use of extra-corporeal membrane oxygenation
- Chronic tracheostomy in place
- Unplanned or accidental extubation
- Terminal/compassionate extubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive ventilation alternating with high flow nasal cannulaA 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. | Device | Intervention Group (NIV with HFNC) |
| High flow nasal cannulaA total of 24 hours of prophylactic respiratory support will be provided using HFNC alone. | Device | Control Group (HFNC alone) |
Primary outcome
Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation
Time frame: 72 hours
Rescue respiratory support is defined as reintubation, use of rescue NIV or HFNC use
1 secondary outcome
Reintubation rate
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramandeep Kaur, PhD principal investigator
Rush University Medical Center
Babak Mokhlesi, MD principal investigator
Rush University Medical Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive ventilation alternating with high flow nasal cannula and High flow nasal cannula in people with Obesity, Morbid and Extubation Failure, run by Rush University Medical Center at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramandeep Kaur, PhD (3129478898, ramandeep_kaur@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.