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Flow- Versus Volume-controlled Ventilation During Robot-assisted Laparoscopic Radical Prostatectomy

Flow- Versus Volume-controlled Ventilation During Robot-assisted Laparoscopic Radical Prostatectomy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07453810
Enrollment
50
Registered
2026-03-06
Start date
2025-11-28
Completion date
2026-03-20
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Positive Pressure Ventilation

Keywords

pulmonary gas exchange, Positive pressure ventilation

Brief 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. 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.

Interventions

Mechanical ventilation delivered in a flow-controlled mode with constant inspiratory and expiratory flow patterns

Mechanical ventilation delivered in a volume-controlled mode with constant tidal volume and decelerating inspiratory flow pattern.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2)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).

Secondary

MeasureTime frameDescription
Driving pressureDuring 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).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.
Mechanical powerDuring 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 (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.
Lung ultrasound scoreLung ultrasound scores (LUS) are assessed at two time points: immediately before anesthesia induction and on the first postoperative day.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.
pulmonary/extrapulmonary complicationsThe first seven postoperative days

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026