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Completed

NCT Number: NCT07453810

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flow-Controlled Ventilation

Device

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

Volume-Controlled Ventilation

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

    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.

  2. 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).

    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.

  3. 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.

    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.

  4. pulmonary/extrapulmonary complications

    Time frame: The first seven postoperative days

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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