A Randomized Cross Over Clinical Trial Assessing the New Provox Life System for Pulmonary Rehabilitation and Quality of Life After Total Laryngectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Average number of forced mucus expectorations per 24 hours
研究概览
简要总结
Background: The benefits of using Heat and Moisture Exchangers (HMEs) for pulmonary rehabilitation after total laryngectomy are widely known. However, current available HMEs do not reach the level of humidification capacity of the nose, and patients adherence to using an HME 24/7 is not always possible. Provox Life HMEs and attachments are a new range of HMEs and attachments, with improved humidification/breathability performance, and designed to suit different situations.
Purpose and aim: In this clinical trial, the new Provox Life System was assessed for pulmonary rehabilitation and QoL after total laryngectomy, and compared with currently available HMEs and attachments.
Methods: Forty laryngectomized patients, who were previous users of HMEs, were randomized to Usual Care or Provox Life for 6 weeks, after which a cross-over occurred. Data was collected at baseline, and after the end of each study period. Additionally, patients filled in a diary and tally sheet to record their forced expectorations and coughing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Provox XtraHME user
- •Provox Adhesive user
- •Longer than 3 months after total laryngectomy
- •Longer than 6 weeks after postoperative radiotherapy
排除标准
- •Medical problems prohibiting the use of HME or adhesive
- •Active recurrent or metastatic disease (medical deterioration)
- •Recent pulmonary infections/unstable pulmonary condition
- •Reduced mobility of arms and/or hands, unable to remove an HME
- •Unable to understand the Patient Information and/or unable to give Informed Consent
- •Insufficient cognitive ability to handle the HME or adhesive
- •LaryButton users
结局指标
主要结局
Average number of forced mucus expectorations per 24 hours
时间窗: during week 6 of period 1 and period 2 (each period is 6 weeks)
Patient reported, recorded by Tally sheeting on 3 days
次要结局
- Average number of (involuntary) dry coughs per 24 hours(during week 6 of period 1 and period 2 (each period is 6 weeks))
- Coughing Symptoms (COUS) domain score of CASA-Q(Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks))
- Coughing Impact (COUI) domain score of CASA-Q(Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks))
- Sputum Symptoms (SPUS) domain score of CASA-Q(Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks))
- Sputum Impact (SPUI) domain score of CASA-Q(Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks))
- Peristomal skin irritation(Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks))
- Average number of days with skin irritation(during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks))
- Quality of Life by EQ-5D-5L(Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks))
- Frequency of using sleeping medication(Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks))
- Average number of hours of HME use per 24 hours(during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks))
- Situational usage pattern of Provox Life HMEs(Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks))
- Patient satisfaction with the Provox Life devices(At the end of Period 1 (Group A), at the end of Period 2 (Group B) (each period is 6 weeks))