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

Not Applicable

Completed

• Conditions: Lung Collapse

• Registration Number: NCT06909630
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2023-01-06
• Study First Submitted: 2023-01-11
• Status Verified: 2024-06
• Primary Completion: 2024-06-12
• Study Completion: 2024-06-14
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post operative pulmonary complication(PPC)	up to PostOperative Day(POD) #3	Post operative lung complication

Secondary Outcome Measures

Name	Time	Method
Individual ventilatory setting	during opertaion	PEEP 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 opertaion	Types 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

Trial Locations

Locations (1)

SNUBH; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of