Trials / Not Yet Recruiting
Not Yet RecruitingNCT07494240
Effects of Changes in Driving Pressure on Intraoperative Pulmonary Dynamic Compliance and PaO₂/FiO₂ Ratio in Laparoscopic Sleeve Gastrectomy
Effects of Changes in Driving Pressure on Intraoperative Pulmonary Dynamic Compliance and PaO₂/FiO₂ Ratio in Patients Undergoing Laparoscopic Sleeve Gastrectomy
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- Sponsor
- Beni-Suef University · Academic / Other
- Sex
- All
- Age
- 20 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this prospective intervention study is to determine whether individualized positive end expiratory pressure (PEEP) titration targeting the minimum Driving pressure (ΔP) during LGS operation improves intraoperative pulmonary dynamic compliance (Cdyn), oxygenation, post operative pulmonary complication (PPCS) Participants will be assigned to two group (incremental - fixed )peep group Researchers will compare the two group to see if peep titration improve lung compliance, lung mechanics intraopertive and PPCS
Detailed description
Obesity (BMI \\ge 30 kg/m\^2) significantly increases the risk of atelectasis and respiratory dysfunction under anesthesia. During Laparoscopic Sleeve Gastrectomy (LSG), the combination of pneumoperitoneum and the Trendelenburg position further impairs lung compliance. Standard lung-protective strategies often use a fixed PEEP, which may be insufficient for obese patients or cause hemodynamic instability if set too high. Fixed PEEP (usually 5 cmH\_2O) does not account for individual variations in chest wall mechanics during laparoscopy. This prospective, randomized, double-blind study involving 46 patients (20-60 years old, BMI 35-40 kg/m\^2). The Intervention * Control Group: Receives a fixed PEEP of 5 cmH\_ throughout the procedure. * Intervention Group: Receives individualized PEEP titration. After a recruitment maneuver, PEEP is adjusted (from 3 to 12 cmH\_2O) to identify the level that achieves the minimum Driving Pressure . This optimal PEEP is then maintained for the surgery. Key Outcomes * Primary: Dynamic pulmonary compliance measured 10 minutes after pneumoperitoneum cessation (T3). * Secondary: Oxygenation (PaO\_2/FiO\_2 ratio), driving pressure levels, postoperative pulmonary complications (PPCs) within 48 hours, and length of hospital stay.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | incremental peep | PEEP will be gradually increased by 1 cmH2O starting from the lowest PEEP allowed by the anesthesia machine (3 cmH2O) to 12 cmH2O, and each PEEP level will be maintained for 10 respiratory cycles and the driving pressure values will be recorded. When driving pressure increased with increasing PEEP, downward PEEP titration will be per- formed until the minimum driving pressure appears |
Timeline
- Start date
- 2026-04-15
- Primary completion
- 2027-09-15
- Completion
- 2027-10-15
- First posted
- 2026-03-27
- Last updated
- 2026-03-27
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT07494240. Inclusion in this directory is not an endorsement.