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Individualized PEEP and Driving Pressure Ventilation on Postoperative Lung Complications in Robot Prostatectomy Surgery

Effects of Individualized PEEP Using Driving Pressure Ventilation on Postoperative Lung Complications in Robot Prostatectomy Surgery: Prospective Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06909630
Enrollment
128
Registered
2025-04-03
Start date
2023-01-06
Completion date
2024-06-14
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Collapse

Brief summary

In the case of robotic prostate cancer surgery under general anesthesia, the surgical posture is extreme Trendelenburg. Therefore, airway pressure is very high during mechanical ventilation, and there is a possibility of postoperative pulmonary complications. In order to prevent postoperative pulmonary complications, we tried to apply end-tidal pressure suitable for each individual to set the most tidal volume that can reduce the burden on the lungs during the perioperative period.

Detailed description

This study is conducted on patients who are scheduled for prostate surgery under general anesthesia with robot assistance. Subjects who consented to the consent form the day before the surgery were conducted with people aged 19 years or older who belonged to the American Society of Anesthesiologists (ASA) class I or II. In the drive group, the ventilator setting is fixed at tidal volume 6-8ml/kg and respiratory rate 15 breathes/min, and then the recruitment maneuver (RM, alveolar recruitment) is performed within the range that does not cause hemodynamic instability. After that, the PEEP is gradually raised from 5 cmH2O to 20 cmH2O. Driving pressure finds the lowest value. If there is no significant change even when the pressure change raises the PEEP, select the lowest PEEP. In the control group, PEEP is maintained in 5 cmH2O until the end of surgery. The primary outcome of the study is to confirm the presence or absence of postoperative pulmonary complications using Chest X-rays, vital signs, and blood tests. It is the individualized PEEP value as a secondary outcome. The related driving pressure and compliance will also be observed. In addition, anesthesia/surgical time, use of vasopressors, amount of blood loss, amount of fluid, and amount of urine will be measured.

Interventions

OTHERDriving pressure group

individual PEEP

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Because a table of random numbers is used, participants do not know which group they belong to.

Intervention model description

In the drive group, the ventilator setting is fixed at tidal volume 6-8ml/kg and respiratory rate 15 breathes/min, and then the recruitment maneuver (RM, alveolar recruitment) is performed within the range that does not cause hemodynamic instability. After that, the PEEP is gradually raised from 5 cmH2O to 20 cmH2O. Driving pressure finds the lowest value. If there is no significant change even when the pressure change raises the PEEP, select the lowest PEEP. In the control group, PEEP is maintained in 5 cmH2O until the end of surgery.

Eligibility

Sex/Gender
MALE
Age
19 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* elective RALP surgery under genenal anesthesia * ASA 1-2 * 19 years of age or older * Consented to participate in the study

Exclusion criteria

* Do not consent to participate in the study * ≥ BMI 40 kg/m2 * Moderate or severe obstructive/restrictive pulmonary disease on pulmonary function tests * Preoperative serious cardiovascular disease * Required postoperative ventilator care at ICU care

Design outcomes

Primary

MeasureTime frameDescription
Post operative pulmonary complication(PPC)up to PostOperative Day(POD) #3Post operative lung complication

Secondary

MeasureTime frameDescription
Individual ventilatory settingduring opertaionPEEP in cmH2O at mechanical ventilation setting static lung compliance in liters/cmH2O at measured mechanical ventilation and calculated driving pressure in cmH20 Driving pressure (DP or ΔP) is defined as the distending pressure above the applied positive end-expiratory pressure (PEEP) required to generate tidal volume (VT) * C stat= tidal volume/ Driving pressure * Driving pressure= tidal volume/C stat
blood pressure(hypotension)during opertaionTypes and dosages of vasopressor agents used when the mean blood pressure is ≤ 60 mmHg. \*\* vasopressor agents: Ephedrine, phenylepherine, Norepinepherine * Ephedrine single intravenous injection: 5mg * phenylepherine single intravenous injection: 20mcg continueous infusion: mcg/kg/min at 100mcg/cc * Norepinepherine continueous infusion: mcg/kg/min at 10mcg/cc

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026