Clinical trial NCT06909630: Individualized PEEP and Driving Pressure Ventilation on Postoperative Lung Complications in Robot Prostatectomy Surgery
Official title: Effects of Individualized PEEP Using Driving Pressure Ventilation on Postoperative Lung Complications in Robot Prostatectomy Surgery: Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Collapse
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 128
Sex: MALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post operative pulmonary complication(PPC)
timeFrame: up to PostOperative Day(POD) #3
Secondary outcomes:
measure: Individual ventilatory setting
timeFrame: during opertaion
measure: blood pressure(hypotension)
timeFrame: during opertaion
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: SNUBH
state: Gyeonggi-do
Study officials:
affiliation: SNUBH
name: Yu kyung Bae
role: PRINCIPAL_INVESTIGATOR
References: