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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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
Are there results?
None posted in the registry

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

Other trials in France

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.
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 groups in NCT04615078
Study groupRoleWhat they receive
"Telemonitoring" groupExperimentalMedical Telemonitoring in Non-Invasive Ventilation
Receives: Device: ETAPES Program
"Standard of Care" groupNo interventionStandard 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.

  1. Nocturnal alveolar hypoventilation data

    Average PtCO2, measured by transcutaneous capnography

    Measured: 6th month

Secondary outcomes (6)

  1. 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

  2. Measurement of diurnal PaO2 and PaCO2

    Measurement of diurnal PaO2 and PaCO2 (mmHg) without NIV, in stable state at rest

    Measured: 6th month

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted4 Nov 2020
  2. Study start18 Jan 2021
  3. Primary completion25 Jul 2022
  4. Study completion25 Jul 2022

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nocturnal alveolar hypoventilation data (time frame: 6th month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04615078, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.

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