NCT07462689

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Ilsan Cha hospital · Academic / Other
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

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

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).

Conditions

• Robot-Assisted Radical Prostatectomy

Interventions

Type	Name	Description
OTHER	PEEP group	Volume-controlled ventilation with PEEP of 5 cmH₂O applied throughout the procedure, without ARM.
OTHER	PEEP + ARM group	Volume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O.

Timeline

• Start date: 2020-12-01
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: South Korea