RecruitingNot ApplicableNCT07207772

EIT-guided PEEP Titration Versus Standard Ventilation in Bariatric Surgery

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


Sponsor

Jianbo Wu

Enrollment

118 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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.

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Interventions

DEVICEGroup P-eit

"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.

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


Locations(1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

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NCT07207772


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