Measurement of FEV1 and Other Physiological Parameters by Connected Devices in Lung Transplanted Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- time series of SpO2 (in %)
研究概览
简要总结
The present study will be a prospective non-interventional study involving 15 to 20 lung transplant patients. The patient will do as usual Forced Expiratory Volume (FEV1) measures and some physiological parameters will be automatically recorded through the wearable and wireless sensors. The spirometer will also be connected but only to transmit stored data, not for real time use. The patient and the physician will not have access to the data until the end of the study. The 6 following physiological parameters will be recorded: heart rate, respiratory rate, body temperature, SPO2, motion, and sleep. The study duration for each patient will be 6 months.
The primary endpoint will be the number of FEV1 measures combined with physiological parameters. This primary endpoint has been chosen because it is easy to obtain. The secondary endpoints will be: - physiological parameters associated with a 10% or higher decrease in FEV1, - correlation between variations of physiological parameters and occurrence of a clinical event (defined by presumption of infection or of graft failure), - interval between the first significant modification of each physiological parameter and the onset of an event, - number of recorded values, - patient's satisfaction. In this pilot phase, there is no real time health advice.
详细描述
Justification of the study: The two main complications responsible for death among lung transplant patients are infection and rejection. In-hospital, 1-year and 5-year mortality is 10%, 20%, and 50%, respectively. The main symptoms are dyspnea, fever, drop in oxygen saturation, drop in pulmonary function tests (FEV1). Investigators hypothesize that surveillance of FEV1 and of several physiologic parameters though connected devices could improve early diagnostic of complications, namely rejection and infection. Surveillance of these patients through connected devices could reduce both mortality and morbidity.
Design of the study: Prospective, observational, monocentric study (Bichat-Hospital, Université Paris 7, France) Main objectives and main endpoint: the main objective is to describe the natural trend of six physiologic parameters (SpO2, heart rate, respiratory rate, cutaneous temperature, physical activity and quality of sleep) and of FEV1 in patients who have benefited from lung transplantation within one year) and to specifically assess the evolution of these parameters a few days before the occurrence of complications. The main criteria of judgment will be mean and standard deviation of these parameters five days before the occurrence of an event, defined by hospitalization for infection and/or graft rejection.
Secondary objectives and secondary endpoints:
The secondary objectives will be:
- To validate metrologic performances of the connected devices.
- To describe the modifications of the physiologic parameters within days before a drop of 10% of FEV1
- To describe the modifications of the physiologic parameters before the occurrence of complications requiring anti-infective and/or anti reject therapies
- To evaluate the interval between modifications of physiologic parameters and the occurrence of infection and/or reject.
- To evaluate the acceptability for the patient and the compliance of connected devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient over 18 years old
- •pulmonary transplant less than a year - consantant - mastering the connected tool
排除标准
- 未提供
结局指标
主要结局
time series of SpO2 (in %)
时间窗: 6 months
specifically assess the evolution of this parameter a few days before the occurrence of complications (occurrence of infection or graft rejection)
次要结局
- time series of cutaneous temperature (in °C)(6 months)
- time series of FEV1 (% of theoretical value)(6 months)
- time series of Heart rate (in bpm)(6 months)
- time series of respiratory rate (in cycles per minute)(6 months)
- time series of physical activity level (measured in a continuous proprietary scale)(6 months)