Actively Recruiting
Prevention of Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Gastric Sleeve Resection by PEEP Titration Based on EIT: A Randomized Controlled Study
Led by Jianbo Wu · Updated on 2025-10-06
118
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of electrical impedance tomography (EIT) to guide individualized positive end-expiratory pressure (PEEP) settings during laparoscopic bariatric surgery. This randomized controlled trial aims to compare EIT-guided PEEP with a fixed PEEP value of 8 cmH2O to see if it reduces the incidence of postoperative pulmonary complications within 72 hours after surgery. The study is conducted at a single center and includes adults undergoing gastric sleeve resection with obesity-related conditions. Participants will be randomly assigned to one of two groups. The EIT-guided group will receive ventilation adjusted by EIT measurements through a recruitment maneuver and decremental PEEP titration after intubation, maintaining individualized PEEP throughout surgery. The control group will receive standard ventilation with a fixed PEEP of 8 cmH2O and volume-controlled ventilation settings. Both groups will undergo recruitment maneuvers at specific times during the procedure. During the study, participants will be monitored for lung function using lung ultrasound scores at several postoperative time points and arterial blood gas analysis during surgery. Researchers will track the occurrence and severity of pulmonary complications up to 72 hours after surgery. The trial includes detailed assessments to evaluate respiratory status and safety, with participation lasting from preoperative preparation through the immediate postoperative period.
CONDITIONS
Brief Title
EIT-guided PEEP Titration Versus Standard Ventilation in Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Scheduled for laparoscopic bariatric surgery under general anesthesia
- American Society of Anaesthesiologists (ASA) physical status I-III
- Body Mass Index (BMI) between 30 and 55 kg/m2
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of smoking or previous thoracic surgery
- Invasive mechanical ventilation within the past 30 days
- Pregnancy
- Allergy to electrical impedance tomography (EIT) electrodes
- Persistent hemodynamic instability or refractory shock
- Severe cardiopulmonary diseases such as severe COPD, NYHA Class III or IV, acute coronary syndrome, or sustained ventricular tachycardia
- Severe pulmonary hypertension (systolic pulmonary artery pressure >40 mmHg)
- Increased intracranial pressure, intracranial injury or tumor, or neuromuscular disorders
- Conversion from laparoscopic surgery to open surgery (laparotomy)
- Planned transfer to intensive care unit after surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants undergo laparoscopic bariatric surgery with mechanical ventilation. Group P-eit participants receive EIT-guided individualized PEEP titration during surgery. Group P-8 participants receive standard ventilation with a fixed PEEP of 8 cmH2O. Recruitment maneuvers are performed after intubation and surgery. Ventilation settings are adjusted during the procedure.
1 visit (in-person during surgery)
Duration - Up to 72 hours post-surgery
Participants are monitored for postoperative pulmonary complications and lung function using lung ultrasound and arterial blood gas analyses within 72 hours after surgery.
3 visits (30 minutes post-extubation, postoperative day 1 morning, postoperative day 2 morning)
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China, 0531
Actively Recruiting
Research Team
J
Jian bo Wu, PH.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here