Positive Pressure VentilationNCT07453810
Flow- Versus Volume-controlled Ventilation During Robot-assisted Laparoscopic Radical Prostatectomy
A study of Positive Pressure Ventilation, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
During robot-assisted laparoscopic radical prostatectomy (RALRP), patients are placed under general anesthesia and supported with mechanical ventilation. In this study, the effects of two different ventilatory strategies-flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV)-were compared. 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
- Positive Pressure Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2025to 20 Mar 2026
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients aged 18 years or older
- American Society of Anesthesiologists physical status (ASA-PS) class I-III
- Scheduled for robot-assisted laparoscopic radical prostatectomy (RALRP)
- Provided written informed consent to participate in the study
Who cannot join
- Patients who declined to participate or withdrew consent
- Conversion from robot-assisted laparoscopic radical prostatectomy to open surgery
- Reoperation within 7 days postoperatively
- Chronic pulmonary disease
- Implanted cardiac devices
- Congestive heart failure New York Heart Association III/IV
- Severe haemodynamic instability after induction of anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
During robot-assisted laparoscopic radical prostatectomy (RALRP), patients are placed under general anesthesia and supported with mechanical ventilation. In this study, the effects of two different ventilatory strategies-flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV)-were compared. Using electrical impedance tomography (EIT) to provide real-time assessment of lung status and to guide individualized positive end-expiratory pressure (PEEP) settings, we investigated whether FCV offers superior oxygenation and improved respiratory system mechanics compared with VCV.
- Conditions
- Positive Pressure Ventilation
- Being tested
- Flow-Controlled Ventilation, Volume-Controlled Ventilation
- Keywords
- pulmonary gas exchange, Positive pressure ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow-Controlled VentilationDevice
Mechanical ventilation delivered in a flow-controlled mode with constant inspiratory and expiratory flow patterns
Volume-Controlled VentilationDevice
Mechanical ventilation delivered in a volume-controlled mode with constant tidal volume and decelerating inspiratory flow pattern.
| Study group | Role | What they receive |
|---|---|---|
| Flow-controlled ventilation (FCV) | Experimental | Patients received intraoperative mechanical ventilation using flow-controlled ventilation during robot-assisted laparoscopic radical prostatectomy. Positive end-expiratory pressure (PEEP) was individualized using electrical impedance tomography (EIT) following a standardized titration protocol. Receives: Device: Flow-Controlled Ventilation |
| Volume-controlled ventilation (VCV) | Active comparator | Patients received intraoperative mechanical ventilation using volume-controlled ventilation during robot-assisted laparoscopic radical prostatectomy. Positive end-expiratory pressure (PEEP) was individualized using electrical impedance tomography (EIT) following the same standardized titration protocol. Receives: Device: Volume-Controlled Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2)
The primary outcome is the PaO2/FiO2 before extubation (T4).
Measured: During the intraoperative period at four predefined time points: after induction of general anesthesia (T1), after pneumoperitoneum and Trendelenburg positioning (T2), 60 minutes after T2 (T3), and before extubation (T4).
Secondary outcomes (4)
Driving pressure
Driving pressure is measured as the difference between plateau pressure and positive end-expiratory pressure (PEEP), with values obtained directly from the ventilator display in the VCV group. In the FCV group, tracheal driving pressure is recorded from the ventilator and corrected for endotracheal tube resistance to calculate alveolar driving pressure, allowing physiologically comparable measurements between groups.
Measured: During the intraoperative period at four predefined time points: after induction of general anesthesia (T1), after pneumoperitoneum and Trendelenburg positioning (T2), 60 minutes after T2 (T3), and before extubation (T4).
Mechanical power
Mechanical power (MP) is calculated from recorded ventilatory parameters. In the volume-controlled ventilation (VCV) group, MP is calculated using respiratory rate, tidal volume, peak airway pressure, and driving pressure. In the flow-controlled ventilation (FCV) group, MP is calculated using minute ventilation, peak pressure, PEEP, and inspiratory flow.
Measured: During the intraoperative period at four predefined time points: after induction of general anesthesia (T1), after pneumoperitoneum and Trendelenburg positioning (T2), 60 minutes after T2 (T3), and before extubation (T4).
Lung ultrasound score
Lung ultrasound (LUS) examination is performed with the patient in the supine position using an ultrasound device equipped with a low-frequency (2.5-5 MHz) convex probe suitable for intercostal imaging. The thoracic surface is systematically evaluated in both longitudinal and transverse planes. For standardized assessment, each hemithorax is divided into anterior, lateral, and posterior regions, and each region is further subdivided into upper and lower areas, resulting in a total of 12 scanning zones. Normal aeration, defined as the presence of A-lines or fewer than two isolated B-lines with preserved lung sliding, is scored as 0. The presence of three or more well-spaced B-lines with preserved sliding is scored as 1. Coalescent B-lines indicating moderate loss of aeration are scored as 2. Pulmonary consolidation is scored as 3. The total LUS score ranges from 0 to 36, with higher scores indicating greater loss of lung aeration.
Measured: Lung ultrasound scores (LUS) are assessed at two time points: immediately before anesthesia induction and on the first postoperative day.
pulmonary/extrapulmonary complications
Measured: The first seven postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start28 Nov 2025
- Primary completion13 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive Pressure VentilationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokcen Kulturoglu, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453810
- Sponsor's protocol ID
- AEŞH-EK-2025-257
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow- Versus Volume-controlled Ventilation During Robot-assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07453810
- Acronym / sponsor ID
- AEŞH-EK-2025-257
- Conditions
- Positive Pressure Ventilation
- Keywords
- pulmonary gas exchange, Positive pressure ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 6 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.
During robot-assisted laparoscopic radical prostatectomy (RALRP), patients are placed under general anesthesia and supported with mechanical ventilation. In this study, the effects of two different ventilatory strategies-flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV)-were compared. Using electrical impedance tomography (EIT) to provide real-time assessment of lung status and to guide individualized positive end-expiratory pressure (PEEP) settings, we investigated whether FCV offers superior oxygenation and improved respiratory system mechanics compared with VCV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flow-controlled ventilation (FCV) | Experimental | Device: Flow-Controlled VentilationPatients received intraoperative mechanical ventilation using flow-controlled ventilation during robot-assisted laparoscopic radical prostatectomy. Positive end-expiratory pressure (PEEP) was individualized using electrical impedance tomography (EIT) following a standardized titration protocol. |
| Volume-controlled ventilation (VCV) | Active comparator | Device: Volume-Controlled VentilationPatients received intraoperative mechanical ventilation using volume-controlled ventilation during robot-assisted laparoscopic radical prostatectomy. Positive end-expiratory pressure (PEEP) was individualized using electrical impedance tomography (EIT) following the same standardized titration protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients aged 18 years or older
- American Society of Anesthesiologists physical status (ASA-PS) class I-III
- Scheduled for robot-assisted laparoscopic radical prostatectomy (RALRP)
- Provided written informed consent to participate in the study
Key exclusion criteria (7 listed)
- Patients who declined to participate or withdrew consent
- Conversion from robot-assisted laparoscopic radical prostatectomy to open surgery
- Reoperation within 7 days postoperatively
- Chronic pulmonary disease
- Implanted cardiac devices
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 |
|---|---|---|
| Flow-Controlled VentilationMechanical ventilation delivered in a flow-controlled mode with constant inspiratory and expiratory flow patterns | Device | Flow-controlled ventilation (FCV) |
| Volume-Controlled VentilationMechanical ventilation delivered in a volume-controlled mode with constant tidal volume and decelerating inspiratory flow pattern. | Device | Volume-controlled ventilation (VCV) |
Primary outcome
The ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2)
Time frame: During the intraoperative period at four predefined time points: after induction of general anesthesia (T1), after pneumoperitoneum and Trendelenburg positioning (T2), 60 minutes after T2 (T3), and before extubation (T4).
The primary outcome is the PaO2/FiO2 before extubation (T4).
4 secondary outcomes
Driving pressure
Time frame: During the intraoperative period at four predefined time points: after induction of general anesthesia (T1), after pneumoperitoneum and Trendelenburg positioning (T2), 60 minutes after T2 (T3), and before extubation (T4).
Mechanical power
Time frame: During the intraoperative period at four predefined time points: after induction of general anesthesia (T1), after pneumoperitoneum and Trendelenburg positioning (T2), 60 minutes after T2 (T3), and before extubation (T4).
Lung ultrasound score
Time frame: Lung ultrasound scores (LUS) are assessed at two time points: immediately before anesthesia induction and on the first postoperative day.
pulmonary/extrapulmonary complications
Time frame: The first seven postoperative days
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 25 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Positive Pressure Ventilation, run by Ankara Etlik City Hospital 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 4 inclusion and 7 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 25 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 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?
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?
The ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) (time frame: During the intraoperative period at four predefined time points: after induction of general anesthesia (T1), after pneumoperitoneum and Trendelenburg positioning (T2), 60 minutes after T2 (T3), and before extubation (T4).). 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 25 Mar 2026.