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

NCT07462689 | Completed DMC

• 1 other identifier: 2017-I021
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Robot-Assisted Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

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.

Other: PEEP group

PEEP + ARM group

ACTIVE COMPARATOR

Volume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O.

Other: PEEP + ARM group

Interventions

PEEP group OTHER

Volume-controlled ventilation with PEEP of 5 cmH₂O applied throughout the procedure, without ARM.

PEEP group

PEEP + ARM group OTHER

Volume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O.

PEEP + ARM group

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ilsan Cha hospital: lead

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang, Gyeonggi-di, 14068, South Korea

Location

Related Publications (9)

• 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.

  PMID: 31141541 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.

  PMID: 19681417 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.

  PMID: 39915702 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.

  PMID: 34710217 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.

  PMID: 10926070 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.

  PMID: 40642630 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.

  PMID: 21179295 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.

  PMID: 20167583 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.

  PMID: 23196259 BACKGROUND

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Eun Young Park

  clinical professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 10, 2026
• Study Start: December 1, 2020
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

KR (1)