NCT06181279

Effects of Individualized PEEP Guided by Driving Pressure on Postoperative Atelectasis in Patients With Morbid Obesity

Effects of Individualized Positive End-expiratory Pressure Guided by Driving Pressure on Postoperative Atelectasis After Bariatric Surgery in Patients With Morbid Obesity: A Single-center, Prospective, Randomized Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Yongtao Sun · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Atelectasis is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. Postoperative atelectasis could last for more than 24h and contribute to a variety of other complications, including hypoxemia and pneumonia. We plan to conduct a single-center, randomized controlled trial in patients undergoing bariatric surgery to test the hypothesis that driving pressure guided PEEP could reduce the postoperative atelectasis.

Detailed description

Positive end-expiratory pressure (PEEP) is a strategy that helps to keep alveoli open during surgery and to prevent postoperative atelectasis. A fixed PEEP without considering the respiratory mechanics in individual patients, however, is not optimal. Individualized PEEP therefore has been increasingly studied, and has been shown to improve oxygenation in both nonobese and obese patients. Studies have shown that the occurrence and prognosis of PPCs are significantly associated with high driving pressure (DP), but not with VT and PEEP. Driving pressure-guided individualized PEEP is expected to be a novel perioperative lung protection strategy. Consequently, the main aim of this study is to investigate the effect of a driving pressure-guided individualized PEEP ventilation strategy on postoperative pulmonary atelectasis in morbidly obese patients undergoing bariatric surgery.

Conditions

• Pulmonary Atelectasis
• Obesity, Morbid

Interventions

Type	Name	Description
PROCEDURE	Individualized PEEP group	Individualized PEEP group: Recruitment Maneuver (RM) is performed first. In pressure control mode, PEEP and airway plateau pressure are increased to 20 cmH2O and 35 cmH2O at a rate of 5 cmH2O every 30s, and driving pressure is maintained at 15 cmH2O throughout. Subsequently, in volume-controlled ventilation mode, PEEP decreases from 20 cmH2O to 4 cmH2O at gradient of 2 cmH2O, and each PEEP level is maintained for 30s. The PEEP corresponding to the lowest driving pressure is the individualized PEEP we need. If multiple PEEP levels showed the same lowest driving pressure, the lowest PEEP value as the individualized PEEP. The above procedures are performed three times during the surgery (5 minutes after intubation,5 minutes after the beginning of pneumoperitoneum, and 5 minutes after the end of pneumoperitoneum).
PROCEDURE	Fixed PEEP group	After the same RM, PEEP is fixed at 8 cmH2O.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-12-26
• Last updated: 2024-06-04

Locations

1 site across 1 country: China