Hallym University Sacred Heart Hospital
Anyang, Gyeonggi-di, 14068, South Korea
NCT Number: NCT07462689
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
Looking for future studies?
Notify Me20 year and older
Male
Interventional
Not applicable
Anyang, Gyeonggi-di, 14068, South Korea
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Volume-controlled ventilation with PEEP of 5 cmH₂O applied throughout the procedure, without ARM.
Volume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O.
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
Ilsan Cha hospital
Other
Comparison of Positive End-expiratory Pressure and Alveolar Recruitment Maneuver on Perioperative Oxygenation in Patients Undergoing Robotic Radical Prostatectomy: a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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