Optimization of Intraoperative Ventilation Guided by Electrical Impedance Tomography in Combination With Oxygen Saturation by Pulse Oximetry (SpO2) Versus SpO2 Alone in Obese Patients Undergoing Robotic Assisted Radical Prostatectomy: Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The arterial oxygen pressure / fraction of inspired oxygen (pO2 /FiO2) ratio
研究概览
简要总结
The primary objective of our study will be verify a possible improvement in arterial oxygenation in the obese patient undergoing robotic-assisted radical prostatectomy if the ventilation will be guided by electrical impedance tomography rather than peripheral saturation alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for laparoscopic radical prostatectomy
- •BMI ≥ 30 kg/m2
排除标准
- •surgery duration < 2 hours
- •history of lung diseases
研究组 & 干预措施
Electrical Impedance Tomography
patient monitored by Electrical Impedance Tomography
干预措施: Electrical Impedance Tomography (Device)
Peripheral arterial Saturation
patient monitored by Peripheral arterial Saturation alone
干预措施: Peripheral arterial Saturation (Device)
结局指标
主要结局
The arterial oxygen pressure / fraction of inspired oxygen (pO2 /FiO2) ratio
时间窗: 16 months
The primary outcome will be the ratio of arterial oxygen pressure and the fraction of inspired oxygen (pO2 / FiO2 ratio) at the end of the intervention, detected by blood gas analysis.
次要结局
未报告次要终点
研究者
Ester Forastiere, MD
Head of Department of Anaestesiology and Critical Care
Regina Elena Cancer Institute