Using EIT to personalize PEEP during bariatric surgery
Prevention of Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Gastric Sleeve Resection by PEEP Titration Based on EIT: A Randomized Controlled Study
NA · Qianfoshan Hospital · NCT07207772
This will test whether using electrical impedance tomography (EIT) to set personalized PEEP during laparoscopic bariatric surgery reduces postoperative lung complications compared with a fixed PEEP of 8 cmH2O in adults with obesity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Qianfoshan Hospital (other) |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07207772 on ClinicalTrials.gov |
What this trial studies
This single-center, single-blind randomized controlled trial will enroll 118 adults undergoing laparoscopic bariatric surgery and randomly assign them to EIT-guided individualized PEEP or a fixed PEEP of 8 cmH2O. The EIT group will have PEEP titrated based on bedside electrical impedance tomography imaging, while the control group will receive conventional lung-protective ventilation with fixed PEEP. The primary outcome is the incidence of postoperative pulmonary complications within 72 hours after surgery, with perioperative respiratory and hemodynamic parameters also recorded. The trial is being conducted at The First Affiliated Hospital of Shandong First Medical University in Jinan, China, with recruitment through the end of 2026.
Who should consider this trial
Good fit: Adults aged 18–65 with BMI 30–55 kg/m2, ASA physical status I–III, scheduled for laparoscopic bariatric surgery and able to give informed consent are the intended participants.
Not a fit: Patients with severe cardiopulmonary disease, recent invasive ventilation, pregnancy, allergy to EIT electrodes, persistent hemodynamic instability, planned ICU transfer, or those who require conversion to open surgery are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, EIT-guided PEEP could lower the rate of early postoperative pulmonary complications by tailoring ventilation to each patient’s lung mechanics.
How similar studies have performed: Physiologic studies and some randomized trials have shown that individualized or EIT-guided PEEP can improve lung mechanics and oxygenation, but evidence for reducing postoperative pulmonary complications in bariatric patients remains limited and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 and 65 years; 2. Plan to receive laparoscopic bariatric surgery under general anesthesia; 3. American Society of Anaesthesiologists (ASA) physical status I-III; 4. BMI between 30 and 55 kg/m2; 5. Voluntary participation in this study and signing of an informed consent form. Exclusion Criteria: 1. History of smoking or previous thoracic surgery; 2. Invasive mechanical ventilation within 30 days; 3. Pregnancy; 4. Allergy to EIT electrodes; 5. Persistent hemodynamic instability or refractory shock; 6. Severe cardiopulmonary disease (e.g., severe COPD (Chronic obstructive pulmonary disease), NYHA (New York Heart Association) Class III or IV, acute coronary syndrome, or sustained ventricular tachycardia); 7. Severe pulmonary hypertension (systolic pulmonary artery pressure \>40 mmHg); 8. Increased intracranial pressure, intracranial injury/tumor, or neuromuscular disorders; 9. Conversion to laparotomy; 10. Planned transfer to intensive care unit after surgery.
Where this trial is running
Jinan, Shandong
- The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital — Jinan, Shandong, China (RECRUITING)
Study contacts
- Principal investigator: NA GUO, MS. — Shandong First Medical University
- Study coordinator: Jian bo Wu, PH.D
- Email: jianbowu@126.com
- Phone: 18560083793
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Electrical Impedance Tomography, Postoperative Pulmonary Complications, Recruitment, Mechanical Ventilation Complication, Obesity, Lung protective ventilation strategy, Recruitment manoeuvre, Conventional lung-protective ventilation