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