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

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.

Study Overview

• Status: Completed
• Conditions: Lung Collapse
• Intervention / Treatment: Other: Driving pressure group

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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • SNUBH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; PEEP is maintained in 5 cmH2O until the end of surgery.
Experimental: Driving pressure group; Individual PEEP is applied according to the driving pressure.	Other: Driving pressure group; individual PEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pulmonary complication(PPC)	Post operative lung complication	up to PostOperative Day(POD) #3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual ventilatory setting	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	during opertaion
blood pressure(hypotension)	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	during opertaion

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Yu kyung Bae, SNUBH

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2023
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): June 14, 2024

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: B-2202-737-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No