An interventional study of Group P-eit and Group P-8 in Electrical Impedance Tomography (EIT), Postoperative Pulmonary Complications (PPCs) and Recruitment, sponsored by Jianbo Wu. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Jianbo Wu · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
In group P-eit, EIT electrode patches will be placed before the operation. "The Recruitment Maneuver - PEEP Titration - Recruitment Maneuver (RM-T-R) Strategy" will be implemented 5 minutes after endotracheal intubation. EIT-based optimal PEEP is defined as the crossing point of the overdistension and collapse curves during a decremental PEEP trial. Other parameters include the individualized PEEP value determined by EIT and inspiratory oxygen fraction (FiO2) of 0.5. PEEP value will be maintained throughout the surgery.All patients in the group P-eit will receive i.v. fluid loading before and a norepinephrine bolus by protocol during the RM in order to maintain a mean arterial pressure \>70mm Hg and minimize the short-lasting haemodynamic depression usually observed during the RM.
Device: Group P-eit
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. The respiratory rate will be adjusted as needed to maintain end-tidal CO₂ between 35 and 45 mmHg throughout the procedure.
Device: Group P-8
"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.
Also known as: PEEP Titration guided by EIT
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.
Also known as: fixed peep =8cmH2O
incidence of postoperative pulmonary complications
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).
Time frame: postoperative within 72 hours
The point-of-care lung ultrasound (LUS) score
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).
Time frame: at 30 minutes after endotracheal extubation, 8:00 AM on postoperative day 1 (POD 1) and postoperative day 2 (POD2).
The severity of PPCs:
(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.
Time frame: postoperative within 72 hours
Arterial blood gas analysis
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.
Time frame: 5 minutes post-intubation (before recruitment maneuver), 1 hour after PNP, at surgery conclusion, and 30 minutes post-extubation.
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