Using noninvasive breathing support for severely obese patients after extubation

A Randomized Controlled Trial of Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

This study is testing if using a combination of noninvasive breathing support methods can help severely obese patients breathe better after being taken off a ventilator and reduce the chances of needing to be put back on one.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rush University Medical Center (other)
• Locations: 5 sites (Chicago, Illinois and 4 other locations)
• Trial ID: NCT05918575 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of noninvasive ventilation (NIV) alternating with high flow nasal cannula (HFNC) in reducing the risk of respiratory failure in severely obese patients who have been extubated. The study aims to determine if this approach can lower the need for reintubation compared to using HFNC alone. Patients eligible for the trial are those who have been on mechanical ventilation for at least 24 hours and have a body mass index (BMI) of 40 kg/m2 or higher. The trial will assess the outcomes of these interventions in a randomized controlled format.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a BMI of 40 kg/m2 or higher who are undergoing planned extubation after at least 24 hours of invasive mechanical ventilation.

Not a fit: Patients who may not benefit from this study include those with chronic tracheostomy, terminal extubation, or contraindications to noninvasive ventilation.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the rates of reintubation and improve recovery outcomes for severely obese patients.

How similar studies have performed: Previous smaller studies have shown that noninvasive respiratory support can reduce reintubation rates in obese patients, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Adult, age ≥ 18 years old
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:

1. Pregnant
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

Where this trial is running

Chicago, Illinois and 4 other locations

• Rush University Medical Center — Chicago, Illinois, United States (RECRUITING)
• Central DuPage Hospital — Winfield, Illinois, United States (NOT_YET_RECRUITING)
• McGovern Medical School, The University of Texas Health Science Center — Houston, Texas, United States (RECRUITING)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)
• Hospital Civil Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico (RECRUITING)

Study contacts

• Principal investigator: Ramandeep Kaur, PhD — Rush University Medical Center
• Study coordinator: Ramandeep Kaur, PhD

Conditions: Obesity, Morbid, Extubation Failure