Electrical Impedance Tomography (EIT)EITNCT07207772
EIT-guided PEEP Titration Versus Standard Ventilation in Bariatric Surgery
A study testing Group P-eit and Group P-8 in people with Electrical Impedance Tomography (EIT) and Postoperative Pulmonary Complications (PPCs), run by Jianbo Wu at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Electrical Impedance Tomography (EIT), Postoperative Pulmonary Complications (PPCs), Recruitment
- What is being tested?
- Group P-eit and Group P-8
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 0531
NA GUO, 18615605135, xinzangbianshu@163.com
About this study
Official title: Prevention of Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Gastric Sleeve Resection by PEEP Titration Based on EIT: A Randomized Controlled Study
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.
- Conditions
- Electrical Impedance Tomography (EIT), Postoperative Pulmonary Complications (PPCs), Recruitment, Mechanical Ventilation Complication, Obesity
- Being tested
- Group P-eit, Group P-8
- Keywords
- Electrical Impedance Tomography (EIT), Postoperative Pulmonary Complications (PPCs), Lung protective ventilation strategy, Recruitment manoeuvre(RM), Conventional lung-protective ventilation, bariatric
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group P-eitDevice
Also called PEEP Titration guided by 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.
Group P-8Device
Also called fixed peep =8cmH2O
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.
| Study group | Role | What they receive |
|---|---|---|
| group P-eit | Experimental | 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. Receives: Device: Group P-eit |
| group P-8 | Active comparator | 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. Receives: Device: Group P-8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 :
- . 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).
Measured: postoperative within 72 hours
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: 5 minutes post-intubation (before recruitment maneuver), 1 hour after PNP, at surgery conclusion, and 30 minutes post-extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start28 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electrical Impedance Tomography (EIT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In group P, after the titration is completed, the ventilator parameters (tidal volume, respiratory rate, and inspiratory-to-expiratory ratio) will be adjusted back to their pre-recruitment settings. 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. The respiratory rate will be adjusted to maintain end-tidal carbon dioxide partial pressure at 35 to 45 mmHg during the operation process. A second recruitment maneuver, identical to the first, will be performed at the end of the procedure.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianbo Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianbo Wu, Qianfoshan Hospital
- Investigators
- NA GUO, MS., Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207772
- Sponsor's protocol ID
- YXLL-KY-2025(107)
- Acronym
- EIT
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Gastric Sleeve Resection by PEEP Titration Based on EIT: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07207772
- Acronym / sponsor ID
- EIT / YXLL-KY-2025(107)
- Conditions
- Electrical Impedance Tomography (EIT), Postoperative Pulmonary Complications (PPCs), Recruitment, Mechanical Ventilation Complication, Obesity
- Keywords
- Electrical Impedance Tomography (EIT), Postoperative Pulmonary Complications (PPCs), Lung protective ventilation strategy, Recruitment manoeuvre(RM), Conventional lung-protective ventilation, bariatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Jianbo WuUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In group P, after the titration is completed, the ventilator parameters (tidal volume, respiratory rate, and inspiratory-to-expiratory ratio) will be adjusted back to their pre-recruitment settings. 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. The respiratory rate will be adjusted to maintain end-tidal carbon dioxide partial pressure at 35 to 45 mmHg during the operation process. A second recruitment maneuver, identical to the first, will be performed at the end of the procedure.
| Arm | Type | Receives |
|---|---|---|
| group P-eit | Experimental | Device: Group P-eitIn 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. |
| group P-8 | Active comparator | Device: Group P-8In 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- History of smoking or previous thoracic surgery;
- Invasive mechanical ventilation within 30 days;
- Pregnancy;
- Allergy to EIT electrodes;
- Persistent hemodynamic instability or refractory shock;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group P-eitAlso: PEEP Titration guided by 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. | Device | group P-eit |
| Group P-8Also: fixed peep =8cmH2OIn 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. | Device | group P-8 |
Primary outcome
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 : 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).
3 secondary outcomes
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 severity of PPCs:
Time frame: postoperative within 72 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Derived from this study: PubMed 42032464Guo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NA GUO, MS. principal investigator
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group P-eit and Group P-8 in people with Electrical Impedance Tomography (EIT) and Postoperative Pulmonary Complications (PPCs), run by Jianbo Wu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian bo Wu, PH.D (18560083793, jianbowu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative pulmonary complications (time frame: postoperative within 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07207772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.