Mechanical Power Ventilation in RALP

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorAnkara City Hospital Bilkent

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years

Elective RALP

ASA I-III

Disqualifiers

Severe pulmonary disease (advanced COPD, ILD)

Preoperative oxygen requirement

Emergency surgery

BMI > 40 kg/m²

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mechanical Power-Targeted Ventilation

    Procedure/Surgery

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

  • Standard Ventilation

    Procedure/Surgery

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Mechanical Power-Targeted VentilationExperimental treatment 2 interventions
Group B: Standard VentilationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Oxygenation Index (OSI)

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

Time frame
postoperative 2nd hour

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

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

Time frame
During surgery (from intubation to extubation)
4

Mechanical power changes

Time frame
During surgery (at predefined intraoperative time points)

Other outcomes

Sponsors and contacts

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