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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Volume-controlled ventilation without application of positive end-expiratory pressure (PEEP) or alveolar recruitment maneuver (ARM). | |
| PEEP group | Active Comparator | Volume-controlled ventilation with PEEP of 5 cmH₂O applied throughout the procedure, without ARM. |
|
| PEEP + ARM group | Active Comparator | Volume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEP group | Other | Volume-controlled ventilation with PEEP of 5 cmH₂O applied throughout the procedure, without ARM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative oxygenation assessed by the arterial partial pressure of oxygen to inspired oxygen fraction ratio | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eun Young Park | clinical professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | Gyeonggi-di | 14068 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31141541 | Background | Cui Y, Cao R, Li G, Gong T, Ou Y, Huang J. The effect of lung recruitment maneuvers on post-operative pulmonary complications for patients undergoing general anesthesia: A meta-analysis. PLoS One. 2019 May 29;14(5):e0217405. doi: 10.1371/journal.pone.0217405. eCollection 2019. | |
| 19681417 | Background | Park HP, Hwang JW, Kim YB, Jeon YT, Park SH, Yun MJ, Do SH. Effect of pre-emptive alveolar recruitment strategy before pneumoperitoneum on arterial oxygenation during laparoscopic hysterectomy. Anaesth Intensive Care. 2009 Jul;37(4):593-7. doi: 10.1177/0310057X0903700419. |
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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| PEEP + ARM group | Other | Volume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O. |
|
| 39915702 | Background | Yessenbayeva GA, Meyerbekova AM, Kim SI, Zhumabayev MB, Berdiyarova GS, Shalekenov SB, Zharlyganova DS, Mukatova IY, Yukhnevich YA, Klyuyev DA, Yaroshetskiy AI. Impact of a positive end-expiratory pressure on oxygenation, respiratory compliance, and hemodynamics in obese patients undergoing laparoscopic surgery in reverse Trendelenburg position: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2025 Feb 7;25(1):61. doi: 10.1186/s12871-025-02933-2. |
| 34710217 | Background | Lagier D, Zeng C, Fernandez-Bustamante A, Vidal Melo MF. Perioperative Pulmonary Atelectasis: Part II. Clinical Implications. Anesthesiology. 2022 Jan 1;136(1):206-236. doi: 10.1097/ALN.0000000000004009. |
| 10926070 | Background | Casati A, Comotti L, Tommasino C, Leggieri C, Bignami E, Tarantino F, Torri G. Effects of pneumoperitoneum and reverse Trendelenburg position on cardiopulmonary function in morbidly obese patients receiving laparoscopic gastric banding. Eur J Anaesthesiol. 2000 May;17(5):300-5. doi: 10.1046/j.1365-2346.2000.00662.x. |
| 40642630 | Background | Tontu F, Akca H, Berktas CK, Asar S, Ozcan FG. The impact of pneumoperitoneum and steep Trendelenburg positioning on novel oxygenation and saturation indices in robot-assisted laparoscopic prostatectomies: A prospective observational study. Saudi J Anaesth. 2025 Jul-Sep;19(3):271-276. doi: 10.4103/sja.sja_600_24. Epub 2025 Jun 16. |
| 21179295 | Background | Suh MK, Seong KW, Jung SH, Kim SS. The effect of pneumoperitoneum and Trendelenburg position on respiratory mechanics during pelviscopic surgery. Korean J Anesthesiol. 2010 Nov;59(5):329-34. doi: 10.4097/kjae.2010.59.5.329. Epub 2010 Nov 25. |
| 20167583 | Background | Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18. |
| 23196259 | Background | Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10. |