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NCT Number: NCT07207772

EIT-guided PEEP Titration Versus Standard Ventilation in Bariatric Surgery

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.

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Key information

Conditions

Electrical Impedance Tomography (EIT) Body Weight Mechanical Ventilation Complication Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Postoperative Pulmonary Complications (PPCs) Recruitment Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Jinan, Shandong, 0531, China

Location status: Recruiting

Location contact

NA GUO

CONTACT

[email protected]

18615605135

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: PEEP Titration guided by EIT

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.

Other names: fixed peep =8cmH2O

Primary outcomes

  1. incidence of postoperative pulmonary complications

    Time frame: postoperative within 72 hours

    Participants who developed at least one complication are considered as meeting the primary outcome. The PPCs are defined as follows :

    • . Pneumonia (using to the US Centres for Disease Control Criteria ;
    • . Respiratory failure
    • . Bronchospasm (newly detected expiratory wheezing treated with bronchodilators);
    • . Pleural effusion
    • . Pneumothorax
    • . Atelectasis
    • . Pulmonary aspiration
    • . 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).

Secondary outcomes

  1. The point-of-care lung ultrasound (LUS) score

    Time frame: at 30 minutes after endotracheal extubation, 8:00 AM on postoperative day 1 (POD 1) and postoperative day 2 (POD2).

    The point-of-care lung ultrasound (LUS) score at 30 min after endotracheal extubation, 8:00 AM on postoperative day 1 (POD 1) and postoperative day 2 (POD2).

  2. The severity of PPCs:

    Time frame: postoperative within 72 hours

    (i) None: planned use of supplemental oxygen or mechanical respiratory support as part of routine care, but not in response to a complication or deteriorating physiology. Therapies that are purely preventive or prophylactic, for example, high-flow nasal oxygen or continuous positive airway pressure (CPAP), should be recorded as none;(ii) Mild: therapeutic supplemental oxygen FiO2< 0.6. (iii) Moderate: therapeutic supplemental oxygen FiO2 ≥ 0.6, requirement for high-flow nasal oxygen, or both. (iv) Severe: unplanned non-invasive mechanical ventilation, CPAP or invasive mechanical ventilation requiring tracheal intubation.

  3. Arterial blood gas analysis

    Time frame: 5 minutes post-intubation (before recruitment maneuver), 1 hour after PNP, at surgery conclusion, and 30 minutes post-extubation.

    Arterial blood gas analysis will be performed at: 5 minutes post-intubation (before recruitment maneuver), 1 hour after PNP, at surgery conclusion, and 30 minutes post-extubation.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian bo Wu, PH.D

CONTACT

[email protected]

18560083793

Sponsors and collaborators

Lead sponsor

Jianbo Wu

Other

Registry information

Official study title

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

Acronym: EIT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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