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临床试验/NCT03202953
NCT03202953已完成不适用

Comparison of Volume Controlled Ventilation With 1:1 Inspiratory to Expiratory Ratio and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum

Yonsei University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2017年7月4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
78
试验地点
2
主要终点
PaO2

研究概览

简要总结

The purpose of this study is to compare the 1: 1 I: E ratio VCV and the autoflow VCV in patients undergoing robot assisted laparoscopic prostatectomy

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

participants, investicator, outcome assessors will be blinded for group allocation.

入排标准

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

入选标准

  • adult (20-80 years old)
  • patients undergoing robot assisted laparoscopic prostatectomy

排除标准

  • history of COPD
  • decreased heart function (EF <50%)
  • patients who cannot read the consent form (e.g., blind, foreigner)

研究组 & 干预措施

1:1 I:E ratio VCV (Group I)

Experimental

volume controlled ventilation with 1:1 inspiratory to expiratory ratio After trendelenburg position, Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:1, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.

干预措施: ventilation strategy 1 (Procedure)

autoflow VCV (Group A)

Active Comparator

autoflow volume-controlled ventilation After trendelenburg position, Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:2, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.

干预措施: ventilation strategy 2 (Procedure)

结局指标

主要结局

PaO2

时间窗: 30 minutes after trendelenburg position

PaO2 analyzed by arterial blood gas analysis

次要结局

  • Arterial blood gas analysis(10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4))
  • PaO2(10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4))
  • End tidal CO2(10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4))
  • peak airway pressure(10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4))
  • blood pressure(10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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