Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02756533 |
| Other study ID # |
38RC15.179 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2016 |
| Est. completion date |
July 6, 2020 |
Study information
| Verified date |
April 2023 |
| Source |
University Hospital, Grenoble |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
COPD is characterized by non-reversible chronic airway obstruction. 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. The
investigators have demonstrated in a previous study that the analysis of parameters from
software embedded in the NIV device can reliably predict the occurrence of an exacerbation.
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 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.
Description:
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.
