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

NCT ID: NCT06909630

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-06
• Study Completion Date: 2024-06-14

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.

Conditions

Lung Collapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control group

PEEP is maintained in 5 cmH2O until the end of surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Driving pressure group

Individual PEEP is applied according to the driving pressure.

Group Type: EXPERIMENTAL

Driving pressure group

Intervention Type: OTHER

individual PEEP

Interventions

Driving pressure group

individual PEEP

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu kyung Bae

Role: PRINCIPAL_INVESTIGATOR

SNUBH

Locations

SNUBH

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-2202-737-002

Identifier Type: -

Identifier Source: org_study_id