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Not yet recruiting NCT07534553

Mechanical Power Ventilation in RALP

No phase Interventional Postoperative Pulmonary Dysfunction Oxygenation Impairment Robot-Assisted Radical Prostatectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mechanical Power-Targeted Ventilation, Standard Ventilation.
Who it may be relevant to
Registry conditions: Postoperative Pulmonary Dysfunction, Oxygenation Impairment, Robot-Assisted Radical Prostatectomy. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Mechanical Power-Targeted Ventilation in Robot-Assisted Laparoscopic Radical Prostatectomy: A Prospective Randomized Controlled Trial

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Oxygenation Index (OSI) [Time frame: postoperative 2nd hour]
Secondary outcome measures (4)
  • PaO₂/FiO₂ ratio [Time frame: Intraoperative period and postoperative 2 hours]
  • Postoperative pulmonary complications (PPC) [Time frame: Within 7 postoperative days]
  • Intraoperative respiratory mechanics [Time frame: During surgery (from intubation to extubation)]
  • Mechanical power changes [Time frame: During surgery (at predefined intraoperative time points)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Bilkent City Hospital — Ankara

Identifiers

NCT: NCT07534553 · E2-26-14834

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗