跳至主要内容
临床试验/NCT00700869
NCT00700869已完成2 期

Phase 2 Study of a New Mechanical Ventilation Weaning Strategy Governs by a Respiratory Behaviour Status Assessment for Patients With Altered Level of Consciousness

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2008年4月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
34
试验地点
1
主要终点
Rate of successful mechanical ventilation weaning at 72 hours

研究概览

简要总结

The purpose of this study is to determine if a weaning strategy from artificial ventilation governs by respiratory behaviour status assessed by our method is safe enough.

详细描述

Current guidelines for mechanical ventilation weaning do not apply for patients with altered level of consciousness. One major limitation is a failure of clinical assessment of the respiratory behaviour status of these patients that are not able to interact appropriately with the examiner. We propose a non-invasive method for the respiratory behaviour assessment of a patient under artificial ventilation that do not requires his participation. Our hypothesis is that, in case of normal respiratory behaviour status, it is possible to wean under security a patient despite his abnormal level of consciousness.We previously demonstrate that patients successfully wean by the clinical team also disclose a normal respiratory behaviour status while patients with weaning failure had abnormal respiratory behaviour. In the present study, we wonder to evaluate that a weaning strategy governs by respiratory behaviour status assessed by our method is safe. For this purpose, in this study, tracheal tube withdrawal is triggered by a recognition of a normal respiratory behaviour status assessed daily in patients under mechanical ventilation with an altered level of consciousness and a good tolerance to T tube challenge.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
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

  • •Altered level of consciousness (-1 < RASS > +1)
  • •Mechanical ventilation ( > 72 hours)
  • •Withdrawal of sedative drugs (> 48 hours)
  • •T tube challenge tolerance
  • •Signed approval for the study by close relative or legal representative

排除标准

  • •Respiratory disease prior to the actual artificial ventilation requirement.
  • •Impairment of upper airway function prior to the actual artificial ventilation requirement.
  • •Pregnancy

研究组 & 干预措施

1

Experimental

Tracheal tube withdrawal governs by respiratory behaviour status

干预措施: mechanical ventilation (Procedure)

结局指标

主要结局

Rate of successful mechanical ventilation weaning at 72 hours

时间窗: 72 hours

次要结局

  • Post tracheal tube withdrawal pneumonia at 72 hours(72 hours)
  • Rate of auto-extubation during patient's participation to the protocol(10 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Evaluation of a New Mechanical Ventilation Weaning... | 临床试验