Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of safe decannulation
研究概览
简要总结
Tracheotomy weaning and decannulation are one of the important problems in the neurosurgical care unit. Aside from medical, psychological, sociological, economical and ethics problems, tracheotomy increases the duration of the hospital stay and conditions the secondarily future medical care (better re-education after the injury).
However, according to investigators practices, that patients who were decannulated with success can go into a secondary care residence more easily.
This research will demonstrate that all patients included can be decannulated without risk of a new recannulation in the 96 hours.
详细描述
Brain injury patients with alertness disorders, wake-up delay and / or swallowing disorders, frequently have a tracheotomy. This tracheotomy is often a problem when it comes to find a bed in a secondary care unit, which is better adapted to the patient rehabilitation. Unfortunately, there is little room to accept this type of patient. It is therefore appropriate to do the weaning during the neurosurgery unit stay.
Bibliographical studies indicate few recommendations as to weaning outside intensive care units. In the neurosurgery units at the University Hospital of Bordeaux, during 3 years (2014-2016), investigators have practiced 29 decannulations without recannulation, over 37 brain injury patients, with a multi-professional team (neurosurgeon, physiotherapist, nurse, caregiver…) to produce a weaning process.
From where investigators hypothesis: using a multi-professional weaning process, checking the patient's stability during the different weaning steps, can lead to decide to decannulate or not without any risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •age at least 18 years old
- •brain-injury disease
- •tracheotomy act while in neurosurgery or reanimation stay
- •no artificial ventilation
- •medical cover
- •free, informed and express consent by the patient or his legal representative (no later than the day after the inclusion and before all exam necessary for the research)
排除标准
- •Malnutrition (defines by the age) :
- •age < 70 years old: body mass index (B.D.I.) <16 kg/m² or albuminemia <20 g/L
- •age > 70 years old: body mass index (B.D.I.) <18 kg/m² or albuminemia <30 g/L
研究组 & 干预措施
Experimental procedure
干预措施: Standardized 5-step weaning procedure (Procedure)
结局指标
主要结局
Number of safe decannulation
时间窗: Up to 3 month after weaning procedure start (Inclusion)
The main objective is to determine the effectiveness of the standardized 5-step weaning procedure for selecting patients to be decannulated without failure. This is measured by the proportion of safe decannulation for all decannulated tracheotomised patients included in the study. The failure of decannulation is defined by a recannulation within 96h.
次要结局
- Life threatening event occurrence during the weaning procedure(Up to 3 month after weaning procedure start (Inclusion))
- Communication capacity with CRS-R (Coma Recovery Scale Revised) communication subscore(Up 6 month after weaning procedure start (Inclusion))
- Nutrition evolution with DOSS (Dysphagia Outcome and Severity Scale) score(Up 6 month after weaning procedure start (Inclusion))
- Mortality at 6 months(6 month after weaning procedure start (Inclusion))
- Reasons of failure in weaning process(Up to 3 month after weaning procedure start (Inclusion))