NCT04835272Unknown不适用
Tracheostomy Decannulation in Severe Acquired Brain Injury: a Decannulation Protocol With Suctioning or Capping?
Fu Xing Hospital, Capital Medical University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2021年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- the time to decannulation
研究概览
简要总结
Single-center randomized trail focused on tracheostomized patients with severe acquired brain injury , comparing two different decannulation protocols:
- an assessment of readiness for decannulation that was based on suctioning frequency
- an assessment that was based on tracheostomy capping
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
- Single (Outcomes Assessor)
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
- •Within three months of onset
- •Age≥18 years old
- •Clinical stability( defined as the absence of fever, sepsis, or active infection and hemodynamic stability)
- •Without massive pooling or silent aspiration of saliva, more than one efficient swallow per minute, adequate cough reflex were tested by gently touching the aryepiglottic region with the tip of the endoscope.
- •Passing a tracheostomy-tube de-cuff test(de-cuff the tube for 3 days without pulmonary complications.
- •Without significant airway stenosis.
排除标准
- •Patients with pending diagnostic or therapeutic procedures and were considered by the clinicians to be at risk for neurologic deterioration
- •Medical history of severe respiratory system or heart disease
- •Neuromuscular disease other than ICU-acquired weakness, or tracheostomy for airway control
- •Don't get informed consent from patient or guardian
研究组 & 干预措施
control group
No Intervention
In the control group, the decision to decannulate was based on a 48-hour capping trial.
intervention group
Experimental
In the intervention group, the decision to decannulate was based on suctioning frequency.
干预措施: the Decannulation Protocol With Suctioning (Procedure)
结局指标
主要结局
the time to decannulation
时间窗: From the date of randomization to decannulation, and the patients will be followed for the duration of hospital stay, an expected average of 3 months
the time from randomization to actual decannulation
次要结局
- Rate of decannulation failure(within 1 week after decannulation)
- high dependency unit length of stay(From the date of high dependency unit admission to transferring to rehabilitation ward, and the patients will be followed for the duration of high dependency unit stay, an expected average of 2 months)
- Rate of respiratory infections(From the date of high dependency unit admission to hospital discharge, and the patients will be followed for the duration of hospital stay, an expected average of 3 months)
- Glasgow Outcome Scale(GOS) six months after the acute brain injury(follow-up six months after discharge)
- Functional Independence Measure(FIM) six months after the acute brain injury(follow up six months after discharge)
研究者
Song Lu
Attending doctor
Fu Xing Hospital, Capital Medical University
研究点 (1)
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