Using noninvasive breathing support for severely obese patients after extubation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rush University Medical Center
  Chicago, Illinois, United States 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
• Central DuPage Hospital
  Winfield, Illinois, United States Not yet recruiting

Study contacts

• Principal investigator: Ramandeep Kaur, PhD — Rush University Medical Center
• Study coordinator: Ramandeep Kaur, PhD
• Email: ramandeep_kaur@rush.edu
• Phone: 3129478898

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting Extubation Problems With Machine Learning

  This study tests whether computer models can predict extubation failure in adults on ventilators in the ICU.

  Recruiting Universitas Indonesia · Jakarta, DKI Jakarta and 1 other locations · NCT07918924

• Glycemic variability after SASI versus Roux-en-Y gastric bypass

  This trial tests whether SASI or Roux-en-Y gastric bypass leads to different glucose fluctuations in adults with severe obesity using continuous glucose monitoring.

  Recruiting Hospitales Universitarios Virgen del Rocío · Seville, Sevilla · NCT07872397

• Postoperative nausea, vomiting and pain after bariatric surgery in Sweden

  This study looks at how often people have nausea, vomiting, and pain after bariatric surgery in Sweden and whether anesthesia type or regional blocks affect those outcomes.

  Recruiting at 2 sites Umeå University · Sundsvall and 1 other locations · NCT07797374

• See if reintubation risk can be predicted after major surgery

  This observational study tests whether ultrasound measurements of the diaphragm and chest muscles, plus the ROX index, can help predict which adults in the ICU after major surgery might need reintubation.

  Recruiting Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Istanbul, Şişli · NCT07672106

• Low-impact laparoscopy for sleeve gastrectomy in adults with obesity

  This will see if low-pressure, small-incision laparoscopy reduces post-surgery pain and improves breathing after sleeve gastrectomy in adults with obesity.

  Recruiting Fondazione Policlinico Universitario Campus Bio-Medico · Rome, Italy · NCT07119437

• Tranexamic acid to reduce bleeding in sleeve gastrectomy and mini gastric bypass

  This trial will test whether giving tranexamic acid before laparoscopic sleeve gastrectomy or mini gastric bypass reduces bleeding in adults with morbid obesity.

  Recruiting Phase 4 Patel Hospital, Pakistan · Karachi, Sindh · NCT07098780

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.