EIT-guided PEEP Titration Versus Standard Ventilation in Bariatric Surgery
Recruiting · NCT07207772 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Group P-8Group P-eit
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- History of smoking or previous thoracic surgery;
- Invasive mechanical ventilation within 30 days;
- Pregnancy;
- Allergy to EIT electrodes;
- Persistent hemodynamic instability or refractory shock;
- 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);
- Severe pulmonary hypertension (systolic pulmonary artery pressure \>40 mmHg);
- Increased intracranial pressure, intracranial injury/tumor, or neuromuscular disorders;
- Conversion to laparotomy;
- Planned transfer to intensive care unit after surgery.
Where it is running
1 location listed.
- The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital - Jinan, Shandong, China