Comparing two ventilation methods for obese patients during bariatric surgery
Driving Pressure Guided Ventilation Versus Conventional Lung Protective Strategy in Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery; a Prospective Randomized Controlled Study
This study is testing if a new way of helping obese patients breathe during bariatric surgery works better than the usual method to see if it helps them recover more safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 2 sites (Tanta and 1 other locations) |
| Trial ID | NCT04861168 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of driving pressure guided ventilation versus conventional lung protective ventilation in morbidly obese patients undergoing laparoscopic bariatric surgery. The primary focus is on intraoperative oxygenation levels, while secondary outcomes include the incidence of postoperative pulmonary complications such as hypoxia and respiratory failure. By comparing these two ventilation strategies, the study aims to determine which method better minimizes lung injury and improves postoperative recovery in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are morbidly obese patients with a BMI between 40-50 kg/m2, aged 18-60, and classified as ASA physical status III, scheduled for laparoscopic bariatric surgery.
Not a fit: Patients with severe respiratory diseases, recent major pulmonary surgeries, or contraindications to PEEP will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory outcomes and reduced complications for morbidly obese patients undergoing surgery.
How similar studies have performed: Previous studies have suggested the potential benefits of driving pressure guided ventilation in similar patient populations, indicating that this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * sixty patients have a BMI 40-50 kg/m2, ASA physical status III, aged between 18 and 60 years, scheduled to undergo laparoscopic bariatric surgeries. Exclusion Criteria: * patient refusal to participate in the study. * Patients had a recent history of severe respiratory disease and previous major pulmonary surgeries. * patients who are contraindicated with application of PEEP (high intracranial pressure, bronchopleural fistula, hypovolemic shock, right ventricular failure).
Where this trial is running
Tanta and 1 other locations
- Tanta University Hospitals — Tanta, Egypt (Not_yet_recruiting)
- Faculty of Medicine — Tanta, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Elbehairy
- Email: mohamedseadana@gmail.com
- Phone: 00201024259293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.