Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients
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
- 1
- 主要终点
- Compliance evolution: mean duration usage (hour per day)
研究概览
简要总结
Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.
Multicentric Randomized Controlled Trial
Primary Objective:
To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term treatment efficacy and patient compliance
Secondary Objectives:
To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with NIV
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •COPD patient already treated by NIV requiring therapy assessment in their routine care Follow-Up or
- •COPD patient requiring de Novo NIV therapy according to routine care rules (NIV<12h)
- •Patient requiring NIV therapy by S9 VPAP ST +/- oxygen therapy
- •Patient willing to participate to the study
- •Patient or attendant able to complete patient passport and to come to Follow-Up visits.
排除标准
- •NIV therapy Failure during screening phase (intolerance, patient refusal, significant leaks, significant AHI or Oxymetry events)
- •Hospitalization conducting to NIV discontinuation for at least 1 week during the screening phase
研究组 & 干预措施
NIV treatment with telemonitoring
telemonitoring is used to manage NIV treatment
干预措施: telemonitoring (Device)
NIV treatment with sham telemonitoring
sham telemonitoring (data not used for NIV management)
干预措施: sham telemonitoring (Device)
结局指标
主要结局
Compliance evolution: mean duration usage (hour per day)
时间窗: 12 months
Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution
时间窗: 12 months
次要结局
- Peripheral oxygen saturation (SP02)(12 months)
- Non-Intentional leaks(12 months)
- Apnea Hypopnea Index (AHI)(12 months)
- St Georges Quality of Life questionnaire(12 months)
- Oxygen desaturation Index (ODI)(12 months)
- 6 Minutes Walking Test (6MWT)(12 months)
- % of patients with Ventilatory asynchronisms(12 months)
- Time with peripheral oxygen saturation (SP02) < 90%(12 months)
- The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity - (BODE) Index(12 months)
- Epworth Sleepiness Scale (ESS)(12 months)
- Mean Noninvasive Ventilation (NIV) use duration (hour/day)(12 months)
- % of days with noninvasive Ventilation (NIV) use ≥ 4h/day(12 months)
- % of days with noninvasive Ventilation (NIV) use < 4h/day(12 months)
- % of days with no Noninvasive Ventilation (NIV) use(12 months)