NL-OMON38448已完成2 期
Phase 2 clinical feasibility study of a new Speaking Valve with a heat- and moisture exchanger (TW) for tracheotomized patients. - Clinical feasibility of the TW
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •is 18 years or older;
- •has a tracheostomy;
- •is spontaneously breathing;
- •has a cuffless tracheostomy tube;
- •has a tracheostomy tube with inner- and outer cannula;
- •currently uses an HME and/or speaking valve.
排除标准
- •is unable to handle or remove the device him/herself when needed, e.g. has decreased level of cognition or reduced mobility of the arms and/or hands;
- •is mechanically ventilated in any way;
- •has a tidal volume of less than100 ml;
- •is suffering from severe aspiration;
- •is laryngectomized; the device will block the possibility to exhale if speaking mode is unintentionally activated;
- •has severe upper airway obstruction, this may cause air trapping;
- •has thick and copious secretions, which might block the device.
研究者
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