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临床试验/NCT02551341
NCT02551341已完成3 期

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

Jørgen Bjerggaard Jensen2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

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

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

No Intervention

normal ventilation

intervention

Experimental

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

发起方
Jørgen Bjerggaard Jensen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jørgen Bjerggaard Jensen

Professor

Aarhus University Hospital

研究点 (2)

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