Oxygenation Impairment, Postoperative Pulmonary Dysfunction, Robot-Assisted Radical Prostatectomy
Conditions
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.
Interventions
PROCEDUREMechanical Power-Targeted Ventilation
Ventilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) using titration of PEEP and respiratory rate.
PROCEDUREStandard Ventilation
Conventional ventilation strategy with fixed PEEP (5 cmH₂O) and routine settings.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Single (Outcome Assessor
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation Index (OSI) | postoperative 2nd hour | OSI calculation: OSI = FiO₂ × MAP × 100 / SpO₂ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 |
| Mechanical power changes | During surgery (at predefined intraoperative time points) | — |
Countries
Turkey (Türkiye)
Contacts
CONTACTBetül Güven Aytaç, Assos Prof
Outcome results
None listed