FreeDom : Innovative Strategy for the Management of COPD Exacerbations Combining Early Hospitalisation Discharge, Automated Oxygen Weaning at Home, Telemedicine and Tele-rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The number of hospital days during COPD exacerbation at day 30.
研究概览
简要总结
The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation.
The main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.
详细描述
The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy will enable an early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation.
The main hypothesis of this study is that a strategy for an early return home with a home hospitalization managed by telemedicine will reduce the length of hospitalization by 50 percent from 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •All patients hospitalized for COPD exacerbation for less than 48 hours will be considered.
- •known or suspected COPD to entry
- •Age > or = 40 years
- •Ex-smoker history (10 pack / year or more)
- •Acute Exacerbation: dyspnea of recent onset (less than 15 days)
- •The need for oxygen therapy with a moderate rate: <6L / min to maintain SpO2 > 90% (for oxygen dependent patient, the oxygen flow must be higher than flow at home)
排除标准
- •Refusal to consent to participate in the study,
- •Indication for an imminent intubation according to the pulmonologist,
- •Sleep Apnea
- •NIV used at home
- •Lack of FreeO2 system available at the time of randomization
- •Non-autonomous and alone at home
- •Patient alone at home
- •Patients who live more than 50 km from the hospital
- •Patient already included in the study within 3 months
研究组 & 干预措施
Control
The intervention is an hospitalization with usual care. The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria
干预措施: Control (Other)
FreeDom
FreeDom strategy (early discharge, automated weaning at home, telemedicine, telereadaptation):
-initial conventional hospitalization before discharge home, O2 flow rate automatically titrated by FreeO2 (based on a SpO2 target). The hospital discharge will be possible if the definite criteria are met.
After hospital discharge, patient will have home hospitalisation. Automated oxygen flow titration, patient education will be conducted for using the telemedicine system, for questionnaires and for the tele-rehabilitation program will be initiated for home hospitalization,
干预措施: FreeDom (Device)
结局指标
主要结局
The number of hospital days during COPD exacerbation at day 30.
时间窗: 30 days
The objective of the study is to reduced the hospitalisation days by 50 % at day 30 during COPD exacerbation
次要结局
- Health Related Quality of Life(1 and 3 months)
- Number of consultations(3 months)
- Rate of Emergency consultation and hospital readmission(1 and 3 months)
- Oxygenation data (% of time in the SpO2 target, % of time with hypoxemia, % of time with hyperoxia)(From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge))
- Cost of care at 3 months(3 months)
研究者
François Lellouche
Principal Investigator
Laval University