Mechanical Power-Targeted Ventilation in Robot-Assisted Laparoscopic Radical Prostatectomy: A Prospective Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Oxygenation Index (OSI)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
Single (Outcome Assessor
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Mechanical Power-Targeted Ventilation
Patients receive ventilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) by titrating PEEP and respiratory rate.
Intervention: Mechanical Power-Targeted Ventilation (Procedure)
Mechanical Power-Targeted Ventilation
Patients receive ventilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) by titrating PEEP and respiratory rate.
Intervention: Standard Ventilation (Procedure)
Standard Ventilation
Patients receive conventional ventilation with fixed PEEP (5 cmH₂O) and routine ventilator settings.
Intervention: Mechanical Power-Targeted Ventilation (Procedure)
Standard Ventilation
Patients receive conventional ventilation with fixed PEEP (5 cmH₂O) and routine ventilator settings.
Intervention: Standard Ventilation (Procedure)
Outcomes
Primary Outcomes
Oxygenation Index (OSI)
Time Frame: postoperative 2nd hour
OSI calculation: OSI = FiO₂ × MAP × 100 / SpO₂
Secondary Outcomes
- 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))
Investigators
Betül Güven
Assos. Prof
Ankara City Hospital Bilkent