Randomized Study To Study the Effect of Lung Protective Ventilation (PEEP) Compared With Normal Ventilation (ZEEP) on Lung Function, Kidney Treatment of Sodium and Water, Vasoactive Hormones, Biomarkers of Nephrotoxicity and Haemodynamics in Patients Undergoing Robot-assisted Radical Prostatectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- PaO2 2 hours postoperatively after 10 minutes of spontaneous respiration of atmospheric air
研究概览
简要总结
Randomized study investigating the effects of lung protective ventilation (PEEP), as compared with normal ventilation (ZEEP) on lung function, treatment of the renal sodium and water, vasoactive hormones, biomarkers of nephrotoxicity, and the circulation of patients undergoing assisted robotic radical prostatectomy
详细描述
Protocol Summary
Purpose:
The project will investigate whether a suspected lung protective ventilator therapy in connection with surgery for cancer of the prostate (prostate) have a relevant beneficial effects on lung function, renal function and circulation associated with keyhole surgery performed with surgical robot.
Trial method:
The trial is a randomized study (randomized controlled trials), which are drawn between normal and a suspected lung protective ventilator treatment in connection with the surgical removal of the prostate due to Cancers. Before the operation, collected urine and blood samples and that a study of lung function and circulation as a starting point. During the operation, and in the following two days collected urine and blood samples. Prepare Furthermore, new studies of lung function and circulation. Blood tests and lung function studied also in outpatient control about 1 week after surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years
- •Indication for robot-assisted radical prostatectomy acc. the department's instructions
排除标准
- •Lack of desire to participate
- •EGFR <15 ml / min
- •BMI> 35 kg / m2
- •Former lung surgery
- •Known requiring treatment lung disease
- •Known heart disease svt NYHA Class III or higher
- •Recent AMI within 12 months
- •Known neuromuscular disease
研究组 & 干预措施
control
normal ventilation
intervention
higher PEEP ventilation
干预措施: higher PEEP ventilation (Procedure)
结局指标
主要结局
PaO2 2 hours postoperatively after 10 minutes of spontaneous respiration of atmospheric air
时间窗: 10 minutes
次要结局
- Difference in cytokines released from lung tissue measured by IL-6.(2 days)
研究者
Jørgen Bjerggaard Jensen
Professor
Aarhus University Hospital
