Robot-Assisted Radical ProstatectomyNCT07462689
Effect of Control Ventilation, PEEP, and PEEP With ARM in Robot-assisted Radical Prostatectomy
A study testing PEEP group and PEEP + ARM group in people with Robot-Assisted Radical Prostatectomy, run by Ilsan Cha hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Robot-Assisted Radical Prostatectomy
- What is being tested?
- PEEP group and PEEP + ARM group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2020to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients with American Society of Anesthesiologists (ASA) physical status I-III scheduled for elective robot-assisted radical prostatectomy under general anesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Sacred Heart Hospital
Anyang, Gyeonggi-di, 14068
About this study
Official title: 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:
Read more
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
Read the 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
- Being tested
- PEEP group, PEEP + ARM group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP groupOther
Volume-controlled ventilation with PEEP of 5 cmH₂O applied throughout the procedure, without ARM.
PEEP + ARM groupOther
Volume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PEEP group |
| PEEP + ARM group | Active comparator | Volume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O. Receives: Other: PEEP + ARM group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative oxygenation assessed by the arterial partial pressure of oxygen to inspired oxygen fraction ratio
PaO₂/FiO₂
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Dec 2020
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Robot-Assisted Radical ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilsan Cha hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Min Lee, Ilsan Cha hospital
- Investigators
- Eun Young Park, Principal investigator, clinical professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462689
- Sponsor's protocol ID
- 2017-I021
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31141541Park 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.
PubMed 19681417Yessenbayeva 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.
PubMed 39915702Lagier 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.
PubMed 34710217Casati 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.
PubMed 10926070Tontu 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.
PubMed 40642630Suh 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.
PubMed 21179295Kalmar 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.
PubMed 20167583Cinnella 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.
PubMed 23196259
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Positive End-expiratory Pressure and Alveolar Recruitment Maneuver on Perioperative Oxygenation in Patients Undergoing Robotic Radical Prostatectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07462689
- Acronym / sponsor ID
- 2017-I021
- Conditions
- Robot-Assisted Radical Prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ilsan Cha hospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Volume-controlled ventilation without application of positive end-expiratory pressure (PEEP) or alveolar recruitment maneuver (ARM). |
| PEEP group | Active comparator | Other: PEEP groupVolume-controlled ventilation with PEEP of 5 cmH₂O applied throughout the procedure, without ARM. |
| PEEP + ARM group | Active comparator | Other: PEEP + ARM groupVolume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with American Society of Anesthesiologists (ASA) physical status I-III scheduled for elective robot-assisted radical prostatectomy under general anesthesia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP groupVolume-controlled ventilation with PEEP of 5 cmH₂O applied throughout the procedure, without ARM. | Other | PEEP group |
| PEEP + ARM groupVolume-controlled ventilation with ARM followed by maintenance PEEP of 5 cmH₂O. | Other | PEEP + ARM group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 31141541Cui 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.
- Background: PubMed 19681417Park 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.
- Background: PubMed 39915702Yessenbayeva 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.
- Background: PubMed 34710217Lagier 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.
- Background: PubMed 10926070Casati 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.
- Background: PubMed 40642630Tontu 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.
- Background: PubMed 21179295Suh 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.
- Background: PubMed 20167583Kalmar 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.
- Background: PubMed 23196259Cinnella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Young Park principal investigator
clinical professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP group and PEEP + ARM group in people with Robot-Assisted Radical Prostatectomy, run by Ilsan Cha hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07462689, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.