JRCT ID: jRCT1052260044
Registered date:11/05/2026
PEEP Setting Using EIT in Robotic Surgery
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Robot Assisted Laparoscopic Surgery |
| Date of first enrollment | 11/05/2026 |
| Target sample size | 50 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | This clinical study assigns patients to two groups based on the method of setting PEEP after the recruitment maneuver (RM). EIT will be applied to both groups. Intervention Group: DFV guided PEEP Group Perform RM after positioning is complete (pneumatic insufflation and patient repositioning finished). After RM completion, set PEEP while monitoring DFV via EIT. PEEP Determination Method Perform RM at 40 cmH2O for 20 seconds. From a starting PEEP of 18 cmH2O, decrease PEEP by 2 cmH2O increments at intervals of 30 seconds or longer until DFV reaches 0.5 to 0.59. PEEP is determined within the range of 18 cmH2O to 5 cmH2O. If DFV 0.5 to 0.59 cannot be achieved, set PEEP to the value closest to this range. Maintain the same PEEP setting during pneumoperitoneum. Adjustments are permitted if deemed necessary for safety and must be documented in the case report. After pneumoperitoneum ends and the patient is repositioned, set PEEP similarly while monitoring DFV via EIT. Control group: Standard PEEP group Similarly, perform RM after positioning. After RM completion, set PEEP to 5 cmH2O. Maintain the same PEEP setting during pneumoperitoneum. Adjusting PEEP when deemed necessary for safety is permitted; record details. Maintain PEEP at 5 cmH2O even after pneumoperitoneum ends and the patient is repositioned. |
Outcome(s)
| Primary Outcome | P/F ratio prior to extubation (T3) T0: After induction of anesthesia T1: After positioning and initiation of pneumoperitoneum, following recruitment maneuver (RM) PEEP set via DFV, 5 minutes later T2: Immediately before pneumoperitoneum release T3: Prior to extubation |
|---|---|
| Secondary Outcome | Efficacy Evaluation Items T1-T2 P/F ratio The following measurements from T1-T3 Intraoperative respiratory dynamics indicators: Driving Pressure (Plateau Pressure - PEEP), Peak Airway Pressure, Mean Airway Pressure, Lung Compliance Arterial Blood Gas Analysis Values: SaO2, PaO2, PaCO2 Postoperative pulmonary complications (PPC) within 7 days Safety Evaluation Items Incidence rate of device-related adverse events occurring from the day of surgery through the observation period in study subjects who received protocol treatment among all enrolled patients |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | < 80age old |
| Gender | Both |
| Include criteria | Patients meeting all of the following criteria will be eligible for inclusion in this study. 1. Patients scheduled to undergo robot-assisted laparoscopic abdominal surgery (intra-pelvic or lower abdominal surgery) under general anesthesia. 2. Patients aged 18 years or older but under 80 years at the time of informed consent acquisition. 3. Patients with a moderate or higher risk of postoperative pulmonary complications. 4.Patients classified as ASA Physical Status I to III 5. Patients from whom written informed consent has been obtained |
| Exclude criteria | Patients meeting any of the following criteria will be excluded. 1. Patients with severe chronic respiratory disease (e.g., severe COPD, receiving home oxygen therapy) 2. Patients with severe obesity (BMI >= 35kg/m2) 3.Pregnant patients 4. Patients with heart failure (NYHA class 3 or higher) or severe arrhythmia 5. Patients with implanted electronic devices such as pacemakers, defibrillators, or neurostimulators 6. Cases where EIT belt application is difficult due to torso deformities 7. Patients with a tracheostomy 8. Cases deemed inappropriate by the principal investigator or sub-investigator |
Related Information
| Primary Sponsor | Miyazaki Atsushi |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Atsushi Miyazaki |
| Address | 7-5-2 Kusunoki-cho, Chuo Ward, Kobe City, Hyogo Prefecture Hyogo Japan 650-0017 |
| Telephone | +81-78-382-6172 |
| amiyazak@med.kobe-u.ac.jp | |
| Affiliation | Kobe university hospital |
| Scientific contact | |
| Name | Atsushi Miyazaki |
| Address | 7-5-2 Kusunoki-cho, Chuo Ward, Kobe City, Hyogo Prefecture Hyogo Japan 650-0017 |
| Telephone | +81-78-382-6172 |
| amiyazak@med.kobe-u.ac.jp | |
| Affiliation | Kobe university hospital |