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临床试验/NCT00927745
NCT00927745已完成4 期

Long Term Clinical Evaluation of AutoFlow Mode During Assist-Controlled Ventilation in ICU Patients

Centre Hospitalier Victor Dupouy1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2002年12月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
42
试验地点
1
主要终点
gas exchange

研究概览

简要总结

The purpose of this study is to evaluate the long term use of AutoFlow mode during mechanical ventilation in ICU patients

详细描述

Many new mechanical ventilation modes are proposed without clinical evaluation. Among them, "dual-controlled" modes, as AutoFlow, are supposed to improve patient-ventilator interfacing, and could led to lesser alarm. This study is a long term clinical evaluation of AutoFlow during assist-controlled ventilation, focusing on its efficacy (on gas exchange and outcome) and on ventilator alarms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • •adult patients under assist-controlled ventilation with an Evita 4 ventilator (Dräger, France) for an expected duration of more than two days

排除标准

  • •ventilation longer than 12 hours prior to inclusion
  • •pregnancy
  • •inclusion in another study

研究组 & 干预措施

With AutoFlow

Experimental

Assist-controlled ventilation with activation of AutoFlow mode

干预措施: AutoFlow mode on Evita 4 Dräger ventilators (Device)

Without AutoFlow

Active Comparator

Assist-controlled ventilation without activation of AutoFlow mode

干预措施: Evita 4 Dräger ventilators (Device)

结局指标

主要结局

gas exchange

时间窗: daily during mechanical ventilation

sedation length

时间窗: ICU discharge

ventilator alarm rates

时间窗: daily during mechanical ventilation

次要结局

  • length of mechanical ventilation(ICU discharge)
  • ventilator asssociated pneumonia rate(ICU discharge)
  • SOFA score(daily during mechanical ventilation)
  • death rate(ICU discharge)
  • cumulative sedation drugs dosage(ICU discharge)

研究者

申办方类型
Other

研究点 (1)

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