Phase 2 Clinical Feasibility Study of a New Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Evaluate Patient Experiences Associated With Exposure to the Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients Based on Results From Questionnaires.
研究概览
简要总结
This clinical investigation addresses the performance of a re-designed The current study aims to investigate the next version of the TW speaking valve, in combination with both a 15mm and 22mm HME cassette.
详细描述
This clinical investigation addresses the performance of a re-designed (updated) speaking valve with Heat and Moisture Exchangers (HME) for tracheotomized patients (project development name 'TW', commercial name 'DualCare'). Study participants trial the new device for 2 weeks after which they can choose to discontinue using the device or continue in the 3 month follow-up part of the study. Clinical feasibility is assessed using structured questionnaires addressing voice and speech, quality of life, breathing, swallowing, olfaction, sleeping, and respiratory symptoms. This is an exploratory, observational study and no specific hypotheses have been formulated.
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
- •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
- •patient 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 than 100 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
研究组 & 干预措施
TW speaking valve/HME
Use of the TW speaking valve/HME
干预措施: TW speaking valve/HME (Device)
结局指标
主要结局
Evaluate Patient Experiences Associated With Exposure to the Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients Based on Results From Questionnaires.
时间窗: 3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device).
Patients were asked to use either the old TW15 and the TW22 HME device for a week, data combined for the two devices (the device used was recorded). After each week, patients completed a device specific questionnaire (Borg Scale). After the re-design (ie Updated speaking valve), patients were asked to use the new Speaking Valve for a week and then to complete relevant sections of the same questionnaire. Both at baseline and in the follow-up, patients were asked about their breathing using a Borg scale at a particular moment. This scale has a range from 0-6 where a score close to "0" indicates less breathing problems.
Hours of HME Use Per Day.
时间窗: Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)
The mean number of hours of TW use per 24 hours was calculated.
Device Preference Rating.
时间窗: Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)
Patients were asked to rate the devices on a scale from 0-10, where "10" indicates the best score and "0" the worst score. The overall mean satisfaction with the speaking valve was rated.
次要结局
未报告次要终点