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

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a specific method of breathing support, called individualized PEEP, can help reduce lung problems after surgery in obese patients. PEEP stands for Positive End-Expiratory Pressure, which helps keep the lungs open during surgery. The study will compare the effects of using individualized PEEP, tailored to each patient's needs, versus a standard fixed level of PEEP during laparoscopic or robotic abdominal surgeries. Researchers want to see if the individualized approach can lead to fewer breathing complications and improve overall recovery in the days and weeks following surgery.

To be eligible for this study, participants must be at least 18 years old with a body mass index (BMI) of 30 or higher, and they should be scheduled for a type of surgery that lasts at least 120 minutes. The trial is not yet recruiting patients, but those who participate will receive either the individualized or fixed PEEP during their surgery and will be monitored for up to 90 days afterward to track their recovery and any complications. This study aims to provide more personalized care for obese patients undergoing surgery, potentially leading to better outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥18 years of age; ASA class I-III. Patients undergoing bariatric laparoscopic or robotic abdominal surgery; BMI ≥30 kg/m²; Planned operative time ≥120 minutes.
• Exclusion Criteria:
• • - Presence of other serious cardiorespiratory diseases, such as severe chronic obstructive pulmonary disease (COPD, GOLD Class III-IV); history of severe or uncontrolled bronchial asthma, history of pulmonary resection; Presence of unstable cardiovascular disease, NYHA classification 3-4, such as severe arrhythmias or heart failure; Presence of neuromuscular disease affecting respiratory function, such as severe spinal cord injury; intracranial injury history of esophageal-related surgery, contraindications to esophageal catheter insertion, including severe coagulopathy (platelets \< 5000/μL or INR \> 4) severe chronic liver disease (Child-Pugh score ≥ 12) Patients who cannot be extubated in time after surgery and need to return to the ICU with an endotracheal tube or are scheduled to be reintubated after surgery.
• • (7) general anesthesia duration less than 120 minutes