Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Forced expiratory volume in one second (FEV1)
研究概览
简要总结
Tracheostomy is performed for prolonged mechanical ventilation. Ineffective bandaging following decannulation leaves the tracheostomy wound unsealed, reducing pulmonary function, coughing ability, and voice quality, ultimately leading to decannulation failure. Recently, a new concept enabling intratracheal sealing of the tracheotomy was introduced, potentially solving the issues of air leakage and tracheal wound infection. This study aims to investigate the feasibility of intratracheal tracheostomy sealing in relation to an immediate normalization of physiological airway flow and an improved voice quality.
详细描述
See protocol document.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Tracheostomy for minimum 7 days
- •Age > 18 years
- •Capped uncuffed tube size 7 or 8 for at least 24 hours
排除标准
- •Cognitive dysfunction (patients who are not able to cooperate with investigation)
结局指标
主要结局
Forced expiratory volume in one second (FEV1)
时间窗: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Lung function / air flow evaluated by spirometry
Voice quality
时间窗: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Evaluated by Equal-Appearing Interval Scale ranging from 1 to 5, where 5 represents a normal voice quality and 1 represents a severely impaired voice
Peak expiratory flow (PEF)
时间窗: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Lung function / air flow evaluated by spirometry
Forced vital capacity (FVC)
时间窗: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Lung function / air flow evaluated by spirometry
次要结局
未报告次要终点