EIT-guided PEEP Titration Versus Standard Ventilation in Bariatric Surgery

Официальное название

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

Обзор

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.

Подробное описание

This is a single-center, single-blind，randomized controlled trial conducted at the First Affiliated Hospital of Shandong First Medical University in Jinan City,Shandong Province, China. This randomized controlled trial has been approved by the Ethics Committee of The First Affiliated Hospital of Shandong First Medical University (YXLL-KY-2025(107)).And it complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. A total of 118 participants will be randomly allocated to the EIT-guided individualized PEEP group (Group P ) (n = 59) or the control group (Group C) (n = 59). Recruitment for this study has begun on July 28, 2025, and will continue through the end of 2026.

Вмешательства

• Устройство Group 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-expirato
• Устройство Group 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

Первичные конечные точки

• incidence of postoperative pulmonary complications [Срок оценки: postoperative within 72 hours]

Вторичные конечные точки (3)

• The point-of-care lung ultrasound (LUS) score [Срок оценки: at 30 minutes after endotracheal extubation, 8:00 AM on postoperative day 1 (POD 1) and postoperative day 2 (POD2).]
• The severity of PPCs: [Срок оценки: postoperative within 72 hours]
• Arterial blood gas analysis [Срок оценки: 5 minutes post-intubation (before recruitment maneuver), 1 hour after PNP, at surgery conclusion, and 30 minutes post-extubation.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Q — Цзинань

Публикации

• Guo N, Ren Y, Liu M, Chen L, Wang X, Wu G, Li X, Feng Y, Li M, Wei C, Sun Y, Wu J. EIT-guided individualized PEEP titration versus conventional lung-protective ventilation to prevent pulmonary complications in laparoscopic bariatric surgery: a study protocol for a randomized controlled trial. BMC Anesthesiol. 2026 Apr 24;26(1):345. doi: 10.1186/s12871-026-03853-5. PMID 42032464

Идентификаторы

NCT: NCT07207772 · YXLL-KY-2025(107)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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