An interventional study of Telemonitoring of daily parameters recorded by NIV and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by University Hospital, Grenoble. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Prevention
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.
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 50 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
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Inclusion Criteria:
Non inclusion Criteria:
Telemonitoring of daily parameters recorded by NIV, transmitted to a remote monitoring platform. When an alert is received the patient is contacted by phone by a nurse to evaluate the worsening of symptoms. Information are transferred to a referent physician for further medical care if needed.
Other: Telemonitoring of daily parameters recorded by NIV
Telemonitoring of daily parameters by NIV, transmitted to a remote monitoring platform with no generation of alerts. Phone calls to patient during the follow-up like "false alerts" for the blind procedure.
Other: Placebo
Daily telemonitoring of breathing rate, % of trigger cycles, daily usage of the NIV will go through an algorithm generating alerts when variations will go beyond normal. When an alert is received, a nurse will evaluate the symptoms of the patient by a standardized phone call questionnaire. The results will be transmitted to a referent practitioner who will decide what the patient should do. Recommendations will be transferred to the patient within 36 hours.
Daily telemonitoring of breathing rate, % of trigger cycles, daily usage of the NIV will go through an algorithm generating alerts when variations will go beyond normal. Alerts will only be collected, the patient will not be contacted by phone during the alert.
Number of hospitalizations for worsening for cardio-respiratory symptoms.
An hospitalization being an entry in any hospital or clinic, whatever the length of the stay. The validation of cardiorespiratory worsening being the reason of the hospitalization will be done by a single independent retrospective committee of two doctors. The doctors won't be investigators of the study.Comparison between the two arms will be done.
Time frame: one year
Number of un-programmed hospitalizations or death
Comparison between the two arms
Time frame: one year
External validation of the algorithm to early detect COPD exacerbation by all parameters recorded by NIV of both groups of patients
all parameters recorded by NIV done will be analyzed according to COPD exacerbations date validated by a single independent retrospective committee of two doctors. The predictive value and sensitivity and the specificity of individual parameters with different algorithm on the previous days of COPD exacerbation will be analyzed. Composite scores of several parameters will be analyzed.
Time frame: one year
Length of hospitalization for worsening of cardio-respiratory symptoms
Comparison between the two arms
Time frame: one year
medical cost
Comparison between the two arms
Time frame: one year
Quality of life assessed by SRI (Severe respiratory Insufficiency) score
Comparison between the two arms of the scores of the SRI questionnaire
Time frame: 1 year
Plan to share: No
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This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble