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临床试验/NCT02803424
NCT02803424已完成不适用

Comparison of Volume Controlled Ventilation and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum

Yonsei University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
arterial oxygen tension (PaO2)

研究概览

简要总结

The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Autoflow-volume controlled ventilation may improve lung compliance and reduce airway peak pressure. Therefore, the aim of this study is to evaluate whether Autoflow-volume controlled ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult male patients scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia

排除标准

  • •chronic obstructive respiratory diseases
  • •heart failure
  • •body mass index (BMI >30 kg/m2)

研究组 & 干预措施

Volume controlled ventilation

Experimental

During the steep trendelenburg position and pneumoperitoneum, volume controlled ventilation will be applied with 8ml/kg (ideal body weight) and inspiration:expiration ratio (I:E) = 1:2.

干预措施: Volume controlled ventilation (Other)

Autoflow-volume controlled ventilation

Active Comparator

During the steep trendelenburg position and pneumoperitoneum, Autoflow-volume controlled ventilation will be applied with 8ml/kg (ideal body weight) and inspiration:expiration ratio (I:E) = 1:2.

干预措施: Autoflow-volume controlled ventilation (Other)

结局指标

主要结局

arterial oxygen tension (PaO2)

时间窗: 30 minutes after steep trendelenburg position and pneumoperitoneum.

Arterial oxygen tension (PaO2) obtained from arterial blood gas analysis

次要结局

  • The peak inspiratory pressure(10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflation.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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