Changes in Pulmonary Outcomes as a Result of Implementing a Day and Night Regimen With Heat and Moisture Exchangers (HMEs) and Their Attachments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Change COUI scores of CASA-Q
研究概览
简要总结
Purpose and Aim: This research is about patients who have had a total laryngectomy, trialing a new range of Heat and Moisture Exchangers (HMEs) - referred to as the "Provox Life™ range of HMEs". The main purpose of this study is to find out if participants experience any differences in the amount of coughing and mucus problems when using the new range of Provox Life™ HMEs (and attachment devices) following an optimal Day/Night regimen. The study is sponsored by Atos Medical.
Study Design: Participants will use the new Provox Life™ HME range and their attachments during two (2) observation phases (Phase 1, Phase 2). In Phase 1 (6 week study phase), participants will use the new Provox Life™ HMEs in a similar way as they currently use their existing HME devices. In the Phase 2 (6 week study phase), they will use the Provox Life™ HME devices following an optimal Day/Night regimen - with the aim to achieve the best possible humidification at all times. Prior to each study phase, participants will meet with their speech pathologist to learn about the new devices and how to use them. Once comfortable using them they will commence each observation phase.
Data Collection: Experiences using their existing HMEs (prior to study) and then using the new HMEs in Phase 1 and Phase 2 will be collected via a series of questionnaires. These will be completed 5 times in total - at baseline before Phase 1 starts, and then at both week 2 and week 6 of Phase 1 and 2. Questionnaires relate to their use of the HMEs, coughing and mucus problems, skin integrity, overall experiences of using the new devices and any impacts on sleep and quality of life. Participants will complete some of the questionnaires at home (approx. 30mins) and the others during an interview session with one of the study team (approx. 30mins). The interview session can be conducted via telephone, videoconferencing or in person - depending on the patients preferences and any COVID restrictions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Total laryngectomy, irrespective of pharynx reconstruction method
- •18 years or older
- •Longer than 3 months after total laryngectomy
- •Longer than 6 weeks after postoperative radiotherapy
排除标准
- •Current day/night routine with Provox Luna
- •Daily use of Provox Micron HMEF
- •Medical problems prohibiting the use of HME
- •Active recurrent or metastatic disease (medical deterioration)
- •Recent pulmonary infections/unstable pulmonary condition
- •Reduced mobility of arms and/or hands, unable to insert or remove an HME
- •Unable to understand the Participant Information and/or unable to give Informed Consent
- •Insufficient cognitive ability to manage HME or adhesive use
结局指标
主要结局
Change COUI scores of CASA-Q
时间窗: Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)
Cough Impact (COUI) assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.
Change in COUS score of CASA-Q
时间窗: Change from End of Phase 1 (week 6) to End of Phase 2 (week 12)
Cough Symptoms (COUS) assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.
次要结局
- Number of forced mucus expectorations per 24 hours(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))
- Number of involuntary coughs per 24 hours(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))
- Jenkins sleep evaluation questionnaire(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))
- Questionnaire to assess Shortness of Breath(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))
- Consumption of medical devices (Number of devices used)(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))
- Study-specific questionnaire to assess number of complications and medical treatments(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))
- Change in SPUS score of CASA-Q(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))
- Questionnaire for Skin Integrity(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))
- Change in SPUI score of CASA-Q(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))
- Change in COUS scores of CASA-Q(Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks))
- Change in COUI scores of CASA-Q(Baseline, Phase 1 (2 weeks), and Phase 2 (2 weeks))
- Questionnaire to adjustment to Day/Night regimen(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))
- Study-specific questionnaire to assess patients satisfaction(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))
- Quality of Life by EQ-5D-5L(Baseline, Phase 1 (2 weeks, 6 weeks), Phase 2 (2 weeks, 6 weeks))