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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

TypeNameDescription
OTHERincremental peepPEEP 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.