Mechanical Power-Targeted Ventilation in Robot-Assisted Laparoscopic Radical Prostatectomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Oxygenation Index (OSI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Single (Outcome Assessor
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Elective RALP
- •ASA I-III
排除标准
- •Severe pulmonary disease (advanced COPD, ILD)
- •Preoperative oxygen requirement
- •Emergency surgery
- •BMI > 40 kg/m²
研究组 & 干预措施
Mechanical Power-Targeted Ventilation
Patients receive ventilation adjusted to achieve the lowest possible mechanical power (≤14 J/min) by titrating PEEP and respiratory rate.
干预措施: 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.
干预措施: Standard Ventilation (Procedure)
Standard Ventilation
Patients receive conventional ventilation with fixed PEEP (5 cmH₂O) and routine ventilator settings.
干预措施: Mechanical Power-Targeted Ventilation (Procedure)
Standard Ventilation
Patients receive conventional ventilation with fixed PEEP (5 cmH₂O) and routine ventilator settings.
干预措施: Standard Ventilation (Procedure)
结局指标
主要结局
Oxygenation Index (OSI)
时间窗: postoperative 2nd hour
OSI calculation: OSI = FiO₂ × MAP × 100 / SpO₂
次要结局
- 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))
研究者
Betül Güven
Assos. Prof
Ankara City Hospital Bilkent