Actively Recruiting
Effect of Individualized High Positive End-expiratory Pressure on Postoperative Pulmonary Rate in Laparoscopic Bariatric Surgeries
Led by Ain Shams University · Updated on 2025-02-17
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of different ventilation strategies on patients with obesity undergoing laparoscopic bariatric surgery. The study focuses on comparing an individualized high positive end-expiratory pressure (PEEP) approach versus a standard PEEP to see how each affects the rate of postoperative pulmonary complications within 10 days after surgery. This research is important because obesity and general anesthesia increase the risk of lung problems after surgery, and tailored ventilation may improve lung function and oxygen levels. Participants will be randomly assigned to one of two groups: one receiving individualized PEEP starting at 7 cmH2O, adjusted to achieve the best static lung compliance for each patient, and the other receiving a standard PEEP of 5 cmH2O during surgery. The study is double-blinded, so neither the patients nor the researchers know which treatment is given to ensure unbiased results. During the study, pulmonary function tests will be conducted on days 1, 3, and 5 after surgery to monitor lung performance. Researchers will carefully observe participants for any lung-related complications up to 10 days post-surgery. The entire process includes preoperative assessments, surgery with assigned ventilation settings, and postoperative monitoring to evaluate outcomes and safety.
CONDITIONS
Brief Title
Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years old
- Body mass index greater than 40
- Scheduled for elective laparoscopic bariatric surgery under general anesthesia
- ARISCAT score of 45 or higher indicating respiratory risk
You will not qualify if you...
- Previous lung surgery
- ASA status III or IV
- Moderate to severe obstructive or restrictive lung disease
- Persistent intraoperative hemodynamic instability
- Need for postoperative mechanical ventilation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo laparoscopic bariatric surgery during which individualized or standard PEEP is applied.
1 surgical visit (in-person)
Duration - 10 days post surgery
Participants are monitored for pulmonary complications and undergo pulmonary function tests after surgery.
3 visits on postoperative days 1, 3, and 5
Trial Site Locations
Total: 1 location
1
Ain shams university
Cairo, Cairo Governorate, Egypt
Actively Recruiting
Research Team
W
wessam selima, MD
G
ghada sharafeldin, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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