Impact of a Telemonitoring Program on the Rate of Hospitalizations for Worsening of Cardio-respiratory Symptoms in COPD Patients Treated at Home by Long-term Non-invasive Ventilation (NIV): a Randomized Controlled Trial

简要总结

详细描述

Chronic Obstructive Pulmonary Disease (COPD) is characterized by non-reversible chronic airway obstruction associated with co-morbidities and is the third leading cause of death worldwide. Its evolution is punctuated by successive exacerbations precipitating the progression of the disease and its co-morbidities. The most severe exacerbations are the source of frequent hospitalizations that strongly affect the patient's quality of life and are associated with increased mortality. The diagnosis of exacerbation is mainly clinical but patients frequently consult their doctor too late which may lead to delays in care. However, the early detection and management of these exacerbations can reduce their impact and in particular avoid hospitalization or shorten their duration. In France, long term Non-Invasive Ventilation (NIV) is a widely used treatment modality in COPD patients with chronic alveolar hypoventilation who have frequent exacerbations. In France, 7000-10000 COPD patients are currently treated with NIV. Recent NIV respirators are fitted with embedded software that provides details on treatment adherence (daily use, number of sessions/day, number of days of use over a given period etc) and on a number of ventilatory parameters measured during treatment (minute ventilation, tidal volume, respiratory rate, leaks, cycles triggered by the patient, etc.). In a preliminary study, including more than 60 COPD patients treated with NIV, the investigators demonstrated that the analysis of parameters from software embedded in the NIV device can reliably predict the occurrence of an exacerbation in following five days. The investigators hypothesize that the daily transmission via a telemonitoring platform of the ventilation parameters of patients, together with an ad hoc warning system, would reduce the rate of hospitalization for COPD patients treated at home with NIV thanks to the early detection and early treatment of these exacerbations. The physiological and symptomatic changes that accompany an exacerbation can be detected by daily questionnaires, monitoring devices worn by the patient or easy to use appliances (respiratory rate sensor, touch pad for daily symptoms). These expensive devices require active patient involvement and a certain degree of skill by the patients, which limits their use. The main innovation of this project is that patients already have NIV treatment reimbursed by their health insurance and no further action will be required on the part of the patient to detect worsening. Changes recorded by the ventilator settings will trigger an alert and if needed early and appropriate patient care can be initiated. Main objective: The purpose of the study is to compare if a program of telemonitoring using the parameters stored by the NIV impact the rate of hospitalization for worsening of cardiorespiratory symptoms in COPD patients versus standard care over a one year period.

主要结局

次要结局

• Number of un-programmed hospitalizations or death(one year)
• Quality of life assessed by SRI (Severe respiratory Insufficiency) score(1 year)
• Length of hospitalization for worsening of cardio-respiratory symptoms(one year)
• External validation of the algorithm to early detect COPD exacerbation by all parameters recorded by NIV of both groups of patients(one year)
• medical cost(one year)