NCT07453810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

February 23, 2026

Last Update Submit

March 21, 2026

Conditions

Positive Pressure Ventilation

Keywords

pulmonary gas exchangePositive pressure ventilation

Outcome Measures

Primary Outcomes (1)

  • The ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2)

    The primary outcome is the PaO2/FiO2 before extubation (T4).

    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

    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

    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 scores (LUS) are assessed at two time points: immediately before anesthesia induction and on the first postoperative day.

  • pulmonary/extrapulmonary complications

    The first seven postoperative days

Study Arms (2)

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.

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.

Device: Volume-Controlled Ventilation

Interventions

Flow-Controlled VentilationDEVICE

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

Flow-controlled ventilation (FCV)
Volume-Controlled VentilationDEVICE

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

Volume-controlled ventilation (VCV)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik City Hospital

Ankara, Ankara, 06170, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 6, 2026

Study Start

November 28, 2025

Primary Completion

March 13, 2026

Study Completion

March 20, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)