Chronic Respiratory Failure With Hypercapniae-VENTNCT04615078
Study Evaluating Telemonitoring and Experimentation in Telemedicine for the Improvement of Healthcare Pathways (ETAPES Program) Compared to Standard of Care in Patients With Chronic Respiratory Failure Receiving Non-invasive Home Ventilation
A study testing ETAPES Program in people with Chronic Respiratory Failure With Hypercapnia and Chronic Obstructive Pulmonary Disease (COPD), run by Air Liquide Santé International at 11 sites in France.
Trial summary
The ETAPES Program, a French national Experimentation in Telemedicine for the Improvement of Healthcare Pathways, was launched in 2018 for 4 years. Its objectives were to provide a temporary public reimbursement for medical telemonitoring in order to determine the benefits for the patient and the impact on medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure With Hypercapnia, Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS)
- What is being tested?
- ETAPES Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 11 sitesFrance
- Study dates
- 18 Jan 2021to 25 Jul 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with chronic respiratory failure for whom treatment with home NIV was prescribed at inclusion or two months earlier, and whose service provider is ADEP Assistance, ADAIR Assistance, ARAIR Assistance or VitalAire,
- Patient who meets all eligibility criteria to participate in the ETAPES program, namely:
- Patient aged 18 and over;
- Patient receiving NIV as part of an indication recognized by the Société de Pneumologie de Langue Française and the Haute Autorité de Santé;
- Patient never before included in the ETAPES program for the remote medical monitoring of their chronic respiratory failure;
- Patient having agreed to participate in the ETAPES program with the Chronic Care Connect Pneumology solution operated by the service providers ADEP Assistance, ADAIR Assistance, ARAIR Assistance or VitalAire, in the event that they are randomized to the Remote Medical Monitoring group;
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- Patient agreeing to the collection of data from their ventilator via remote transmission;
- Patient fitted with a ventilator compatible with the Chronic Care Connect Pneumology solution;
- Patient with health insurance cover;
- Patient who has signed the consent form for the study.
Who cannot join
- Patient who has any of the non-eligibility criteria for the ETAPES program:
- Physical or mental inability to use all components of the remote medical monitoring project, as determined by the doctor wishing to include the patient in the remote medical monitoring project;
- Patient with cancer with a life expectancy of less than 12 months estimated by the pulmonologist;
- Patient with more than three COPD respiratory decompensations resulting in hospitalization within the previous 12 months;
- Patient with diagnosed neuromuscular disease;
- Estimated poor compliance or standard adherence to treatment according to the physician including the patient;
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- Patient's refusal of treatment support;
- No permanent place of residence;
- Patient participating in another intervention research program.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Centre Hospitalier de Boulogne sur Mer
Boulogne-sur-Mer, 62321
Centre Hospitalier de Bligny
Briis-sous-Forges, 91640
Claude SCHMITZ, MD
Colmar, 68000
Hôpital Forcilles - Fondation Cognacq-Jay
Férolles-Attilly, 77150
François BUGHIN, MD - Clinique du Millénaire
Montpellier, 34000
Clinique FSEF Paris 16ème
Paris, 75016
Groupe Hospitalier Pitié Salpêtrière-Charles Foix
Paris, 75651 cedex 13
Groupe Médical de Pneumologie, Polyclinique Saint Laurent
Rennes, 35706
Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey
Toulouse, 31059
Centre Hospitalier Universitaire de Tours - Hôpital Bretonneau
Tours, 37044
Pierre-Henri GUILLAUD, MD
Vienne, 38200
About this study
Official title: Multi-center, National, Randomized, Exploratory Study Evaluating Telemonitoring and Experimentation in Telemedicine for the Improvement of Healthcare Pathways (ETAPES Program) Compared to Standard of Care in Patients With Chronic Respiratory Failure Receiving Non-invasive Home Ventilation (e-VENT)
The ETAPES Program, a French national Experimentation in Telemedicine for the Improvement of Healthcare Pathways, was launched in 2018 for 4 years. Its objectives were to provide a temporary public reimbursement for medical telemonitoring in order to determine the benefits for the patient and the impact on medical organization and healthcare costs. In particular, this program applies to patients suffering from hypercapnic chronic respiratory failure and requiring home non invasive ventilation (NIV). For these patients, the ETAPES program combines NIV telemonitoring and therapeutic education.
e-VENT study aims at evaluating the ETAPES program, implemented using the Chronic Care Connect™ telemonitoring solution, versus Standard of Care, on the effectiveness of home NIV, measured by average PtCO2, reflecting the level of nocturnal alveolar hypoventilation.
Read the detailed description
A prospective randomized study with two arms.
The primary endpoint is the level of nocturnal alveolar hypoventilation, defined as the average PtCO2 in nocturnal capnography performed at 6th month.
Patients with hypercapnic chronic respiratory failure requiring home NIV (n=100).
Multi-center study conducted in France involving approximately 20 sites
Product under study: Chronic Care Connect Pneumology telemonitoring solution, combining:
- a technical solution for the transmission and analysis of ventilator data, with the generation of alerts by a CE-marked algorithm;
- an organizational solution relying on a nurse call center.
Study design:
- First visit: eligibility criteria confirmation; randomization to 2 groups:
- the "Telemonitoring" group will participate in the ETAPES experimentation, with remote monitoring of their ventilator data with generation of alerts to the nurse call center, medical action if requested, and therapeutic education.
- the "Standard of Care" group will receive standard medical follow-up, with transmission of their ventilator data without generation of alerts.
- Second visit (6th month): arterial blood gases, nocturnal capnography. Collection of medical events having occurred in the past 6 months.
- Third visit (12th month): for COPD patients only - Collection of medical events having occurred in the past 6 months.
- At the end of the study, the investigators will complete a qualitative questionnaire on their telemonitoring practice.
- Conditions
- Chronic Respiratory Failure With Hypercapnia, Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS)
- Being tested
- ETAPES Program
- Keywords
- Non-invasive ventilation, Telemonitoring, Remote Patient Management, ETAPES, Home healthcare provider, Chronic Care Connect Pneumology
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETAPES ProgramDevice
Also called Chronic Care Connect Pneumology Solution
The Chronic Care Connect Pneumology is a remote medical monitoring solution, combining:
- A technical solution for the transmission and analysis of ventilator data, leading to alerts generated by an algorithm ;
- An organizational solution relying on a nurse call center.
| Study group | Role | What they receive |
|---|---|---|
| "Telemonitoring" group | Experimental | Medical Telemonitoring in Non-Invasive Ventilation Receives: Device: ETAPES Program |
| "Standard of Care" group | No intervention | Standard medical follow-up: standard home Non-Invasive Ventilation service, with transmission of their ventilator data without analysis leading to alerts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal alveolar hypoventilation data
Average PtCO2, measured by transcutaneous capnography
Measured: 6th month
Secondary outcomes (6)
Number of medical events (consultations, hospitalizations and COPD exacerbations) related to Chronic Respiratory Failure
Average number of medical events (consultations, hospitalizations and COPD exacerbations) related to Chronic Respiratory Failure per patient
Measured: 6th month; 12th month
Measurement of diurnal PaO2 and PaCO2
Measurement of diurnal PaO2 and PaCO2 (mmHg) without NIV, in stable state at rest
Measured: 6th month
S3-NIV questionnaire
Questionnaire evaluating sleep, side effects and symptoms in patients on home NIV, each time the service provider visits the patient at home
Measured: Through study completion, an average estimated at around 7 months
DIRECT questionnaire
Total health-related quality-of-life score from the DIRECT questionnaire as recommended in the ETAPES program, submitted to the patients in the month following their inclusion and in the 6th month
Measured: 1st month; 6th month
Quality of NIV treatment
Daily data teletransmitted by ventilators throughout the follow-up period
Measured: Through study completion, an average estimated at around 7 months
Patient satisfaction questionnaire about Telemonitoring services
Questionnaire developed for the study to collect patient satisfaction about the educational component of the telemonitoring service at the end of their participation to the study
Measured: 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start18 Jan 2021
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory Failure With HypercapniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnaud PRIGENT, MD, Principal investigator, Groupe Médical de Pneumologie, Polyclinique Saint Laurent - 35706 - Rennes - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615078
- Sponsor's protocol ID
- ALMED-20-001
- Other IDs
- 2020-A02150-39
- Acronym
- e-VENT
- Status last verified
- Jun 2023
- First submitted
- 20 Oct 2020
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prigent A, Texereau JB, Schmitz C, Ropars C, Degreef JM, Teulier M, Darne C, Lavergne F, Pasche H, Morelot-Panzini C. Real-world telemonitoring and remote support for home non-invasive ventilation to improve therapy effectiveness: the exploratory, multicentre randomised eVENT study. Thorax. 2025 Sep 15;80(10):720-729. doi: 10.1136/thorax-2024-222033.
PubMed 40169180