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

NCT06909630 | Completed

• 1 other identifier: B-2202-737-002
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Collapse

Outcome Measures

Primary Outcomes (1)

• Post operative pulmonary complication(PPC)

  Post operative lung complication

  up to PostOperative Day(POD) #3

Secondary Outcomes (2)

• Individual ventilatory setting

  during opertaion

• blood pressure(hypotension)

  during opertaion

Study Arms (2)

Control group

NO INTERVENTION

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

Driving pressure group

EXPERIMENTAL

Individual PEEP is applied according to the driving pressure.

Other: Driving pressure group

Interventions

Driving pressure group OTHER

individual PEEP

Driving pressure group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

SNUBH

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yu kyung Bae

  SNUBH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Because a table of random numbers is used, participants do not know which group they belong to.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: April 3, 2025
• Study Start: January 6, 2023
• Primary Completion: June 12, 2024
• Study Completion: June 14, 2024
• Last Updated: April 3, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)