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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PostoperativePulmonaryComplications
• Intervention / Treatment: Device: Transpulmonary pressure-guided individualized PEEP

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transpulmonary pressure-guided individualized PEEP group; Preoperative assessment was performed based on basic information such as patient's age, height, weight, BMI classification, pulmonary function and blood gases. Intraoperatively, a ventilation strategy based on esophageal pressure (Pes) to monitor the transpulmonary pressure guidance was adopted, 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 with PEEP at the level of Pes+1 cm H2O.	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.
No Intervention: The fixed PEEP; The fixed PEEP group was the intraoperative ventilation strategy based on lung protection, using a small tidal volume (6-8 ml/kg of ideal body weight) and setting the PEEP level at 8 cmH2O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PostoperativePulmonaryComplications	The primary outcome was acomposite of pulmonary complications within the first 7 postoperative days, including respiratory failure, acute respiratory distress syndrome, bronchospasm, new pulmonaryinfiltrates, pulmonary infection, aspiration pneumonitis, pleural effusion, atelectasis, cardiopulmonary edema, and pneumothorax.	From enrollment to seven days postoperatively

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 21, 2025
• First Submitted That Met QC Criteria: May 21, 2025
• First Posted (Actual): May 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: E20241048A; E20241048A-1 (Other Identifier: TianjinCIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No