Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of required days to obtain a 4-hours-night ventilation
研究概览
简要总结
Neuromuscular diseases are frequently associated with respiratory failure, which requires Non Invasive Ventilation (NIV). Currently, the NIV installation is done during an hospitalization of several days. This hospitalization is problematic because of availability of beds, logistical difficulties for the patient and estrangement from the usual environment.
For this reasons, the NIV installation at home could be an interesting alternative for both the patient and the medical staff.
The aim of this pilot study is to test the feasibility of NIV installation at home, using telemedicine as a remote monitoring tool, and to assess its impact on the ventilation compliance.
详细描述
For the study protocol, patients will be hospitalized for the first day to define the ventilation mode and initial parameters, and to choose the best adapted interface.
Then, the patient is discharged from hospital and parameters adaptation is continued at home during the following five days by the hospital medical staff, using telemedicine. An ASV Santé employee visits the patient at home everyday during 5 days to ensure follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Man or Women aged over 18 years
- •Neuromuscular disease or kyphoscoliosis
- •At least one sign among : dyspnea, orthopnea, daytime sleepiness, cephalalgia, asthenia
- •At least one sign among : hypercapnia > 45 mmHg, desaturation time < 88%, night desaturation time > 5 min, Vital Capacity < 60% or Pimax < 60 cm H2O.
排除标准
- •Mechanic ventilation refusal
- •Patient living alone
- •Acute respiratory failure
- •Patient who need a third party for the ventilation installation
- •Severe respiratory limitation
- •Home oxygen
结局指标
主要结局
Number of required days to obtain a 4-hours-night ventilation
时间窗: 5 days
次要结局
- Number of non programmed home visits(5 days)
- Number of ventilation hours per 24 hours during the 5 first days(5 days)
- Capno-oximetry improvement at D5(5 days)
- Clinical signs decrease (symptoms, dyspnea, drowsiness)(30 days)
- Number of hospitalization for respiratory or ventilation disorder(30 days)
- Quality of life (SF36) at D1 and D30(30 days)
- Economic cost evaluation(5 days)
- Satisfaction scale for the patient and his family at D5 and D30(30 days)
- Capno-oximetry and arterial blood gases improvement at D30(30 days)
- Number of skin slough caused by interface position(30 days)
- Reliability of telemonitoring(5 days)
- Reliability of telemedicine(5 days)
研究者
david orlikowski
coordinating physician - professor
Centre d'Investigation Clinique et Technologique 805