Clinical trial

EIT-guided PEEP Titration Versus Standard Ventilation in Bariatric Surgery

Recruiting now · Not applicable · 1 countries · Registry ID NCT07207772

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionElectrical Impedance Tomography (EIT), Postoperative Pulmonary Complications (PPCs), Recruitment, Mechanical Ventilation Complication, Obesity

Full registry 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.

Treatments and study arms

Group P-eit

Device

"The Recruitment Maneuver - PEEP Titration - Recruitment Maneuver (RM-T-R) Strategy" will be implemented 5 minutes after endotracheal intubation. The patient will receive an RM (peak pressure 50cm H2O, PEEP 25cmH2O, respiratory rate 6 bpm, for 10 cycles) followed by a decremental PEEP titration, during which PEEP is set to 25cm H2O and decreased stepwise by 2cm H2O every 3min until reaching 5 cmH₂O. Meanwhile, the ventilator parameters (tidal volume, respiratory rate, and inspiratory-to-expiratory ratio) will be adjusted back to their pre-recruitment settings. EIT-based optimal PEEP is defined as the crossing point of the overdistension and collapse curves during a decremental PEEP trial.

Group P-8

Device

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-eit. The respiratory rate will be adjusted as needed to maintain end-tidal CO₂ between 35 and 45 mmHg throughout the procedure.

Primary outcomes

incidence of postoperative pulmonary complicationspostoperative within 72 hours

Participants who developed at least one complication are considered as meeting the primary outcome. The PPCs are defined as follows : 1. . Pneumonia (using to the US Centres for Disease Control Criteria ; 2. . Respiratory failure 3. . Bronchospasm (newly detected expiratory wheezing treated with bronchodilators); 4. . Pleural effusion 5. . Pneumothorax 6. . Atelectasis 7. . Pulmonary aspiration 8. . Cardiogenic pulmonary oedema (clinical signs of congestion, including dyspnoea, oedema, rales, and jugular venous distention, with chest X-ray demonstrating an increase in vascular markings and diffuse alveolar interstitial infiltrates).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital🇨🇳 Jinan, Shandong, China

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