Prevention of Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Gastric Sleeve Resection by PEEP Titration Based on EIT: A Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is a prospective, single-center, single-blind, randomized controlled clinical trial. Patients scheduled for laparoscopic bariatric surgery will be selected and randomly assigned to either the EIT-guided individualized PEEP group (Group P-eit) or the control group (Group P-8). Group P will be ventilated using the PEEP value determined by EIT, while Group C will be ventilated with a fixed PEEP value of 8 cmH2O.The primary outcome is the incidence of postoperative pulmonary complications (PPCs) within 72 hours after surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age between 18 and 65 years;

• Plan to receive laparoscopic bariatric surgery under general anesthesia;

• American Society of Anaesthesiologists (ASA) physical status I-III;

• BMI between 30 and 55 kg/m2;

• Voluntary participation in this study and signing of an informed consent form.

Locations
Other Locations
China
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
RECRUITING
Jinan
Contact Information
Primary
Jian bo Wu, PH.D
jianbowu@126.com
18560083793
Time Frame
Start Date: 2025-07-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 118
Treatments
Experimental: group P-eit
In group P-eit, EIT electrode patches will be placed before the operation. The Recruitment Maneuver - PEEP Titration - Recruitment Maneuver (RM-T-R) Strategy will be implemented 5 minutes after endotracheal intubation. EIT-based optimal PEEP is defined as the crossing point of the overdistension and collapse curves during a decremental PEEP trial. Other parameters include the individualized PEEP value determined by EIT and inspiratory oxygen fraction (FiO2) of 0.5. PEEP value will be maintained throughout the surgery.All patients in the group P-eit will receive i.v. fluid loading before and a norepinephrine bolus by protocol during the RM in order to maintain a mean arterial pressure \>70mm Hg and minimize the short-lasting haemodynamic depression usually observed during the RM.
Active_comparator: group P-8
In group P-8, mechanical ventilation will be administered in volume-controlled mode with a tidal volume of 8 ml/kg (based on ideal body weight). Additional settings include a PEEP of 8 cmH₂O, FiO₂ of 0.5, an inspiratory-to-expiratory ratio of 1:2, and a respiratory rate of 12 breaths/min. A recruitment maneuver (RM) will be performed 5 minutes after intubation and again after surgery, using the same protocol as in group P. The respiratory rate will be adjusted as needed to maintain end-tidal CO₂ between 35 and 45 mmHg throughout the procedure.
Related Therapeutic Areas
Sponsors
Leads: Jianbo Wu

This content was sourced from clinicaltrials.gov