NCT05482022招募中不适用
Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
Loewenstein Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change from baseline oxygen saturation
研究概览
简要总结
Speaking valve seems to have a beneficial influence on breathing and secretion management in certain patients with tracheostomy.
The investigators plan to use a speaking valve during respiratory physical therapy sessions in participants with disturbances of consciousness, who have a tracheostomy, with no need of a mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •brain injury (traumatic/non-traumatic).
- •tracheostomy.
- •unresponsive wakefulness syndrome or minimally conscious state.
- •fiber optic examination as follows: good mobilization of the vocal cords. No airway granulation, MarianJoy scale score: 1-
- •the legal guardian speaks Hebrew.
排除标准
- •airway stenosis / inflammation.
- •oxygen saturation <90%.
结局指标
主要结局
change from baseline oxygen saturation
时间窗: 15 minutes
at physical therapy sessions
change from baseline breathing rate
时间窗: 15 minutes
at physical therapy sessions
次要结局
- rate of swallowing(15 minutes)
- percentage of participants presenting vocalization(2 weeks)
- cough rate(2 weeks)
- percentage of patients weaned from tracheostomy(through study completion, an average of 6 months.)
研究者
elena eidinov
Head of Intensive Care for Consciousness Rehabilitation Department
Loewenstein Hospital
研究点 (1)
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