Mechanical Power Ventilation in RALP

NCT07534553 | Not Yet Recruiting

• 1 other identifier: E2-26-14834
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pulmonary Dysfunction; Oxygenation Impairment; Robot-Assisted Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Oxygenation Index (OSI)

  OSI calculation: OSI = FiO₂ × MAP × 100 / SpO₂

  postoperative 2nd hour

Secondary Outcomes (4)

• PaO₂/FiO₂ ratio

  Intraoperative period and postoperative 2 hours

• Postoperative pulmonary complications (PPC)

  Within 7 postoperative days

• Intraoperative respiratory mechanics

  During surgery (from intubation to extubation)

• Mechanical power changes

  During surgery (at predefined intraoperative time points)

Study Arms (2)

Mechanical Power-Targeted Ventilation

EXPERIMENTAL

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; Procedure: Standard Ventilation

Standard Ventilation

ACTIVE COMPARATOR

Patients receive conventional ventilation with fixed PEEP (5 cmH₂O) and routine ventilator settings.

Procedure: Mechanical Power-Targeted Ventilation; Procedure: Standard Ventilation

Interventions

Mechanical Power-Targeted Ventilation PROCEDURE

Ventilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) using titration of PEEP and respiratory rate.

Mechanical Power-Targeted Ventilation; Standard Ventilation

Standard Ventilation PROCEDURE

Conventional ventilation strategy with fixed PEEP (5 cmH₂O) and routine settings.

Mechanical Power-Targeted Ventilation; Standard Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe pulmonary disease (advanced COPD, ILD)
• Preoperative oxygen requirement
• Emergency surgery
• BMI \> 40 kg/m²

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Central Study Contacts

Betül Güven Aytaç, Assos Prof

CONTACT

0905073578351; drbguven@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single (Outcome Assessor
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assos. Prof

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

TU (1)