Postoperative Pulmonary DysfunctionNCT07534553
Mechanical Power Ventilation in RALP
A study testing Mechanical Power-Targeted Ventilation and Standard Ventilation in people with Postoperative Pulmonary Dysfunction and Oxygenation Impairment, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Robot-assisted laparoscopic radical prostatectomy (RALP) requires steep Trendelenburg positioning and pneumoperitoneum, which adversely affect respiratory mechanics and may lead to impaired postoperative oxygenation. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pulmonary Dysfunction, Oxygenation Impairment, Robot-Assisted Radical Prostatectomy
- What is being tested?
- Mechanical Power-Targeted Ventilation and Standard Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Elective RALP
- ASA I-III
Who cannot join
- Severe pulmonary disease (advanced COPD, ILD)
- Preoperative oxygen requirement
- Emergency surgery
- BMI > 40 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara
Betül Güven Aytaç, Assos prof, 0905073578351, drbguven@hotmail.com
About this study
Official title: Mechanical Power-Targeted Ventilation in Robot-Assisted Laparoscopic Radical Prostatectomy: A Prospective Randomized Controlled Trial
Robot-assisted laparoscopic radical prostatectomy (RALP) requires steep Trendelenburg positioning and pneumoperitoneum, which adversely affect respiratory mechanics and may lead to impaired postoperative oxygenation.
Mechanical power (MP) has recently emerged as a comprehensive parameter reflecting the total energy delivered from the ventilator to the respiratory system and may be associated with ventilator-induced lung injury.
Read more
This prospective randomized controlled trial aims to evaluate whether a mechanical power-targeted ventilation strategy improves postoperative oxygenation compared to standard ventilation in patients undergoing RALP.
The primary outcome is the oxygenation index (OSI) at the postoperative second hour. Secondary outcomes include PaO₂/FiO₂ ratio, postoperative pulmonary complications, and length of hospital stay.
- Conditions
- Postoperative Pulmonary Dysfunction, Oxygenation Impairment, Robot-Assisted Radical Prostatectomy
- Being tested
- Mechanical Power-Targeted Ventilation, Standard Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Power-Targeted VentilationProcedure or surgery
Ventilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) using titration of PEEP and respiratory rate.
Standard VentilationProcedure or surgery
Conventional ventilation strategy with fixed PEEP (5 cmH₂O) and routine settings.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Power-Targeted Ventilation | Experimental | Patients receive ventilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) by titrating PEEP and respiratory rate. Receives: Procedure: Mechanical Power-Targeted Ventilation; Procedure: Standard Ventilation |
| Standard Ventilation | Active comparator | Patients receive conventional ventilation with fixed PEEP (5 cmH₂O) and routine ventilator settings. Receives: Procedure: Mechanical Power-Targeted Ventilation; Procedure: Standard Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation Index (OSI)
OSI calculation:
OSI = FiO₂ × MAP × 100 / SpO₂
Measured: postoperative 2nd hour
Secondary outcomes (4)
PaO₂/FiO₂ ratio
Measured: Intraoperative period and postoperative 2 hours
Postoperative pulmonary complications (PPC)
Measured: Within 7 postoperative days
Intraoperative respiratory mechanics
Dynamic compliance (Cdyn, mL/cmH₂O) Static compliance (Cstat, mL/cmH₂O) Peak airway pressure (Ppeak, cmH₂O) Plateau pressure (Pplat, cmH₂O) Driving pressure (ΔP = Pplat - PEEP, cmH₂O) Mean airway pressure (MAP, cmH₂O) Airway resistance
Measured: During surgery (from intubation to extubation)
Mechanical power changes
Measured: During surgery (at predefined intraoperative time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary DysfunctionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534553
- Sponsor's protocol ID
- E2-26-14834
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Power-Targeted Ventilation in Robot-Assisted Laparoscopic Radical Prostatectomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07534553
- Acronym / sponsor ID
- E2-26-14834
- Conditions
- Postoperative Pulmonary Dysfunction, Oxygenation Impairment, Robot-Assisted Radical Prostatectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 16 Apr 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.
Robot-assisted laparoscopic radical prostatectomy (RALP) requires steep Trendelenburg positioning and pneumoperitoneum, which adversely affect respiratory mechanics and may lead to impaired postoperative oxygenation.
Mechanical power (MP) has recently emerged as a comprehensive parameter reflecting the total energy delivered from the ventilator to the respiratory system and may be associated with ventilator-induced lung injury.
This prospective randomized controlled trial aims to evaluate whether a mechanical power-targeted ventilation strategy improves postoperative oxygenation compared to standard ventilation in patients undergoing RALP.
The primary outcome is the oxygenation index (OSI) at the postoperative second hour. Secondary outcomes include PaO₂/FiO₂ ratio, postoperative pulmonary complications, and length of hospital stay.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical Power-Targeted Ventilation | Experimental | Procedure: Mechanical Power-Targeted Ventilation, Procedure: Standard VentilationPatients receive ventilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) by titrating PEEP and respiratory rate. |
| Standard Ventilation | Active comparator | Procedure: Mechanical Power-Targeted Ventilation, Procedure: Standard VentilationPatients receive conventional ventilation with fixed PEEP (5 cmH₂O) and routine ventilator settings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Elective RALP
- ASA I-III
Key exclusion criteria (4 listed)
- Severe pulmonary disease (advanced COPD, ILD)
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 |
|---|---|---|
| Mechanical Power-Targeted VentilationVentilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) using titration of PEEP and respiratory rate. | Procedure or surgery | Mechanical Power-Targeted Ventilation, Standard Ventilation |
| Standard VentilationConventional ventilation strategy with fixed PEEP (5 cmH₂O) and routine settings. | Procedure or surgery | Mechanical Power-Targeted Ventilation, Standard Ventilation |
Primary outcome
Oxygenation Index (OSI)
Time frame: postoperative 2nd hour
OSI calculation: OSI = FiO₂ × MAP × 100 / SpO₂
4 secondary outcomes
PaO₂/FiO₂ ratio
Time frame: Intraoperative period and postoperative 2 hours
Postoperative pulmonary complications (PPC)
Time frame: Within 7 postoperative days
Intraoperative respiratory mechanics
Time frame: During surgery (from intubation to extubation)
Mechanical power changes
Time frame: During surgery (at predefined intraoperative time points)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Power-Targeted Ventilation and Standard Ventilation in people with Postoperative Pulmonary Dysfunction and Oxygenation Impairment, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 16 Apr 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Güven Aytaç, Assos Prof (0905073578351, drbguven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation Index (OSI) (time frame: postoperative 2nd hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2026.