NCT06996288

A Multicenter Randomized Controlled Clinical Trial of the Impact of Minimally Invasive Abdominal Surgery Esophageal Pressure Monitoring Guided Individualized PEEP on Postoperative Pulmonary Complications in Obese Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the effect of individualized PEEP based on transmural lung pressure and fixed PEEP on postoperative pulmonary complications during laparoscopic or robotic abdominal surgery in obese patients. The main questions are: 1. whether the intraoperative application of individualized PEEP in obese patients can reduce the incidence of postoperative pulmonary complications at 7d, 30d, and 90d postoperatively compared to fixed PEEP 2. Whether the application of individualized PEEP in obese patients can optimize intraoperative respiratory mechanics, oxygenation index (PaO2/FiO2), PaCO2, and EtCO2 compared with fixed PEEP. 3 Whether the application of individualized PEEP in obese patients can reduce the incidence of non-respiratory complications, postoperative QoR-15 scores, unplanned reintubation, unplanned transfers, and unplanned extubation in the postoperative period compared with fixed PEEP. planned reintubation, unplanned transfers to ICU and ICU days, hospitalization days, 30-day and 90-day mortality. Participants will: Patients with BMI \>= 30 kg/m² undergoing laparoscopic or robotic abdominal surgery received PEEP during surgery (divided into individualized PEEP and fixed PEEP), and were followed up for 90 days to observe the incidence of pulmonary complications and related study outcomes.

Conditions

• PostoperativePulmonaryComplications

Interventions

Type	Name	Description
DEVICE	Transpulmonary pressure-guided individualized PEEP	Transpulmonary pressure-guided individualized PEEP group was an intraoperative ventilation strategy based on esophageal pressure (Pes) monitoring of transpulmonary pressure-guided ventilation, using a small tidal volume (6-8 ml/kg of ideal body weight), maintaining the transpulmonary pressure in the safe range of 5-15 cmH2O PEEP for Pes+1 cm H2O level.

Timeline

• Start date: 2025-05-20
• Primary completion: 2027-05-31
• Completion: 2027-12-31
• First posted: 2025-05-30
• Last updated: 2025-05-30