Mechanical Power Ventilation in RALP

April 10, 2026 updated by: Betül Güven, Ankara City Hospital Bilkent

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥18 years
  • Elective RALP
  • ASA I-III

Exclusion Criteria:

  • Severe pulmonary disease (advanced COPD, ILD)

    • Preoperative oxygen requirement
    • Emergency surgery
    • BMI > 40 kg/m²

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mechanical Power-Targeted Ventilation
Patients receive ventilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) by titrating PEEP and respiratory rate.
Procedure: Mechanical Power-Targeted Ventilation
Ventilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) using titration of PEEP and respiratory rate.
Procedure: Standard Ventilation
Conventional ventilation strategy with fixed PEEP (5 cmH₂O) and routine settings.
Active Comparator: Standard Ventilation
Patients receive conventional ventilation with fixed PEEP (5 cmH₂O) and routine ventilator settings.
Procedure: Mechanical Power-Targeted Ventilation
Ventilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) using titration of PEEP and respiratory rate.
Procedure: Standard Ventilation
Conventional ventilation strategy with fixed PEEP (5 cmH₂O) and routine settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation Index (OSI)
Time Frame: postoperative 2nd hour

OSI calculation:

OSI = FiO₂ × MAP × 100 / SpO₂
postoperative 2nd hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaO₂/FiO₂ ratio
Time Frame: Intraoperative period and postoperative 2 hours
Intraoperative period and postoperative 2 hours
Postoperative pulmonary complications (PPC)
Time Frame: Within 7 postoperative days
Within 7 postoperative days
Intraoperative respiratory mechanics
Time Frame: During surgery (from intubation to extubation)
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
During surgery (from intubation to extubation)
Mechanical power changes
Time Frame: During surgery (at predefined intraoperative time points)
During surgery (at predefined intraoperative time points)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • E2-26-14834

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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