Effect of Control Ventilation, PEEP, and PEEP With ARM in Robot-assisted Radical Prostatectomy

March 5, 2026 updated by: Jung Min Lee, Ilsan Cha hospital

Comparison of Positive End-expiratory Pressure and Alveolar Recruitment Maneuver on Perioperative Oxygenation in Patients Undergoing Robotic Radical Prostatectomy: a Randomized Controlled Trial

The goal of this clinical trial is to determine whether different ventilatory strategies improve oxygenation and hemodynamic stability in patients undergoing robot-assisted radical prostatectomy under general anesthesia. The study will also evaluate the safety and physiological effects of applying positive end-expiratory pressure (PEEP) and alveolar recruitment maneuver (ARM) during surgery.

The main questions this study aims to answer are:

Does the application of PEEP or PEEP combined with ARM improve intraoperative oxygenation compared with conventional mechanical ventilation?

How do PEEP and ARM affect intraoperative hemodynamic parameters such as cardiac output and stroke volume during pneumoperitoneum and steep Trendelenburg positioning?

Are there any adverse events associated with the use of these ventilatory strategies during surgery?

Researchers will compare three ventilation strategies-conventional ventilation without PEEP, ventilation with PEEP alone, and ventilation with PEEP combined with ARM-to evaluate their effects on perioperative oxygenation and cardiovascular function.

Participants will:

Undergo robot-assisted radical prostatectomy under general anesthesia

Be randomly assigned to receive one of three ventilatory strategies during surgery

Receive standardized anesthetic management and intraoperative monitoring

Have arterial blood gas analysis and hemodynamic measurements performed at predefined time points during surgery and recovery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the ARM group, alveolar recruitment maneuvers were performed three times at predefined time points after pneumoperitoneum and Trendelenburg positioning: 40 minutes (T2), 70 minutes (T3), and 110 minutes (T4) after pneumoperitoneum. ARM was conducted using a stepwise increase in PEEP with a maximum peak inspiratory pressure of 40 cmH₂O: PEEP was increased from 4 to 8 cmH₂O for 3 breaths, from 8 to 12 cmH₂O for 3 breaths, and from 12 to 16 cmH₂O for 10 breaths.

Sample size calculation was based on data obtained from a pilot study, using the PaO₂/FiO₂ ratio as the primary outcome for comparison among the three groups. Assuming an effect size of 0.25, a statistical power of 0.80, and a two-sided significance level of 0.05, a total sample size of 48 patients was required. To account for a potential dropout rate of 20%, a total of 60 patients were enrolled in the study.

Repeated measurements of PaO₂/FiO₂ ratio and other longitudinal variables will be analyzed using repeated-measures analysis of variance or generalized estimating equations, as appropriate. A p-value <0.05 will be considered statistically significant. Statistical analyses will be performed using SPSS version 30 (IBM Corp., Armonk, NY, USA).

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Gyeonggi-di
      • Anyang, Gyeonggi-di, South Korea, 14068
        • Hallym University Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients with American Society of Anesthesiologists (ASA) physical status I-III scheduled for elective robot-assisted radical prostatectomy under general anesthesia

Exclusion Criteria:

  • uncontrolled asthma, chronic obstructive pulmonary disease (defined as a forced expiratory volume in 1 second to forced vital capacity ratio <60% or forced expiratory volume in 1 second <60% of the predicted value)
  • hypoxemia (oxygen saturation <90% on room air)
  • left ventricular ejection fraction <50%
  • hypotension (systolic blood pressure <90 mmHg)
  • body mass index ≥30 kg/m²
  • conversion to open surgery, or intraoperative events that precluded protocolized ventilation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Volume-controlled ventilation without application of positive end-expiratory pressure (PEEP) or alveolar recruitment maneuver (ARM).
Active Comparator: PEEP group
Volume-controlled ventilation with PEEP of 5 cmH₂O applied throughout the procedure, without ARM.
Other: PEEP group
Volume-controlled ventilation with PEEP of 5 cmH₂O applied throughout the procedure, without ARM.
Active Comparator: PEEP + ARM group
Volume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O.
Other: PEEP + ARM group
Volume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative oxygenation assessed by the arterial partial pressure of oxygen to inspired oxygen fraction ratio
Time Frame: T0 (15 min after induction), T1 (10 min after pneumoperitoneum and Trendelenburg), T2 (30 min after T1), T3 (30 min after T2), T4 (30 min after T3), T5 (before the end of surgery), and T6 (30 min after arrival in the post-anesthesia care unit)
PaO₂/FiO₂
T0 (15 min after induction), T1 (10 min after pneumoperitoneum and Trendelenburg), T2 (30 min after T1), T3 (30 min after T2), T4 (30 min after T3), T5 (before the end of surgery), and T6 (30 min after arrival in the post-anesthesia care unit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ilsan Cha hospital

Investigators

  • Principal Investigator: Eun Young Park, clinical professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

March 1, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-I021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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