CClinicalTrials.gg
RecruitingNCT07207772EITUpdated Oct 6, 2025

EIT-guided PEEP Titration Versus Standard Ventilation in Bariatric Surgery

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

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Electrical Impedance Tomography (EIT)
  • Postoperative Pulmonary Complications (PPCs)
  • Recruitment
  • Mechanical Ventilation Complication
  • Obesity

Browse trials for

Keywords

  • Electrical Impedance Tomography (EIT)
  • Postoperative Pulmonary Complications (PPCs)
  • Lung protective ventilation strategy
  • Recruitment manoeuvre(RM)
  • Conventional lung-protective ventilation
  • bariatric
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 118 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Jianbo Wu is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
118 participants (estimated)

Study arms

  • Experimental
    group P-eit

    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

  • Active comparator
    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. 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

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.

    Also known as: PEEP Titration guided by EIT

  • 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.

    Also known as: fixed peep =8cmH2O

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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

  3. 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.

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
    Jinan, Shandong 0531, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 42032464 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07207772
Lead sponsor
Jianbo Wu
Responsible party
Jianbo Wu (professor, Qianfoshan Hospital) — Sponsor-investigator
First posted
Oct 6, 2025
Start date
Jul 28, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 6, 2025

Study contacts

Jian bo Wu, PH.D
Contact
jianbowu@126.com
18560083793
NA GUO, MS.
principal investigator · Shandong First Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion