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NCT Number: NCT07534553

Mechanical Power Ventilation in RALP

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.

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Key information

Conditions

Postoperative Pulmonary Dysfunction Oxygenation Impairment Robot-Assisted Radical Prostatectomy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Mechanical Power-Targeted Ventilation

Procedure

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

Standard ventilation

Procedure

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

Primary outcomes

  1. Oxygenation Index (OSI)

    Time frame: postoperative 2nd hour

    OSI calculation:

    OSI = FiO₂ × MAP × 100 / SpO₂

Secondary outcomes

  1. PaO₂/FiO₂ ratio

    Time frame: Intraoperative period and postoperative 2 hours

  2. Postoperative pulmonary complications (PPC)

    Time frame: Within 7 postoperative days

  3. 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

  4. Mechanical power changes

    Time frame: During surgery (at predefined intraoperative time points)

Study contacts

Contact information is provided by the study sponsor or research team.

Betül Güven Aytaç, Assos Prof

CONTACT

[email protected]

0905073578351

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 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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