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临床试验/NCT02620358
NCT02620358已完成不适用

Two Opposite Strategies of Weaning From Mechanical Ventilation: High Work of Breathing Versus Low Work of Breathing

Althaia Xarxa Assistencial Universitària de Manresa0 个研究点目标入组 1,190 人开始时间: 2016年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,190
主要终点
Succesful extubation rate

研究概览

简要总结

This study compares two opposite strategies of weaning from Mechanical Ventilation. One of them is Low Pressure Support Ventilation during 30 minutes and the other is T-Tube for 2 hours. The aim of the study is to know witch one has a higher successful extubation rate.

详细描述

The final stage of weaning from Mechanical Ventilation is known as Spontaneous Breathing Test (SBT). Some studies in the last 20 years have compared different strategies of weaning.

The SBT using T-Tube versus Low Pressure Support Ventilation (PSV) for 2 hours didn't show differences in successful extubation.

No difference in successful extubation rate were seen with the T-Tube for 30 or 120 minutes, or the Low PSV for 30 minutes or 2 hours For this reason the actual guidelines recommend to use T-Tube or Low PSV from 30 minutes to 2 hours with the same level of evidence.

Nevertheless, no studies have compared two opposite strategies like T-Tube for 2 hours (High work of breathing) versus Low PSV for only 30 minutes (Low work of breathing). Whereas the high work of breathing approach can be more specific for detecting more fitted patients, the low work of breathing method may reduce fatigue during SBT allowing more patients to be extubated.

We have designed a prospective, multicentric controlled and randomized study to compare this two opposite strategies of weaning: T-Tube for 120 minutes versus PSV 8 cmH2O for 30 minutes.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • More tan 18 years old
  • More tan 24 hour of Mechanical Ventilation ready for weaning

排除标准

  • Tracheostomy
  • Non reintubation orders

结局指标

主要结局

Succesful extubation rate

时间窗: 72 hours

Rate of succesful extubation after one of the weaning strategy

次要结局

  • Reintubation rate(72 hours)
  • ICU Length of Stay(3 month)
  • Hospital Length of Stay(3 month)
  • Mortality(3 month)

研究者

发起方
Althaia Xarxa Assistencial Universitària de Manresa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carles Subirà Cuyàs

Physician

Althaia Xarxa Assistencial Universitària de Manresa

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