Assessment of the Home Non-invasive Compliance in Patients With Chronic Obstructive Pulmonary Disease Following the Introduction of Long-term Ventilation. An Observational Study

Compliance of Long-term Home Non-invasive Ventilation for Patients With Chronic Obstructive Pulmonary Disease

Sponsors

Lead sponsor: Vivisol

Collaborator: Slb Pharma
France Oxygène
MBar

Source Vivisol
Brief Summary

Background : Long-term home non-invasive ventilation (NIV) can be proposed as treatment for acute respiratory failure with severe alveolar hypoventilation. The aim of NIV is to correct both daytime and night-time hypoventilation and associated symptoms and to provide the patient with adequate night-time oxygen saturation. The benefits of long-term NIV in the management of chronic obstructive pulmonary disease (COPD) patients in a stable state remain controversial. This highlights the importance of identifying the predictive factors for good compliance to the NIV, defined as a use of more than 4 hours per day.

Aim of the study: The main objective is this observational study is to monitor the home NIV compliance over a period of 1 year under real conditions of treatment in patients with COPD newly initiated onto NIV (with telemonitoring or not) in order to specify the predictive criteria for good compliance. The secondary objectives are to assess the evolution of functional respiratory data, NIV parameters and changes in prescription, occurrence of acute exacerbations of COPD, hospitalizations and death, patient outcomes (quality of life and acceptability of NIV).

Study design: a cohort of 120 patients with COPD newly initiated onto home-NIV (with telemonitoring or not), either in a stable state or following an acute exacerbation will be enrolled in the study and follow-up over 1 year. Data will be collected by lung specialists and home health care provider teams at 1-month post-initiation of NIV, 6 months and 1 year. The study is conduct in France.

Overall Status Recruiting
Start Date February 25, 2020
Completion Date March 31, 2022
Primary Completion Date March 31, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Assessment of the global compliance of the home-NIV over 1 year 1 year
Secondary Outcome
Measure Time Frame
Evolution of the mean duration of NIV use per day month 1, month 6, month 12
Impact of the home-NIV on the medical condition of COPD patients 1 year
Impact of the home-NIV on the dyspnea At inclusion, month 6, month 12
Impact of the home-NIV on the respiratory function At inclusion, month 6, month 12
Impact of the home-NIV on the health related quality of life of COPD patients At inclusion, month 6
Assessment of home-NIV by patients month 6
Enrollment 120
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- COPD patients who require the initiation of a home-NIV (in case of previous equipment: NIV interrupted for more than 6 months).

- Life expectancy greater than 1 year.

- Patient who has agreed to participate in the observational study after receiving clear information from the investigator and signing the consent form.

Exclusion Criteria:

- NIV indicated for the treatment of chronic respiratory failure other than COPD.

- Patient with overlap syndrome (COPD associated to OSA).

- Patient with limitations who do not allow proper use of the NIV device.

- Simultaneous participation in a health intervention research.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Gilles Jébrak, MD Principal Investigator Bichat Hospital, Paris
Overall Contact

Last name: Anne-Laure Sérandour

Phone: +33 2 99 12 19 62

Email: [email protected]

Location
facility status contact
Pays d'Aix hospital | Aix-en-Provence, 13616, France Recruiting Stéphanie Martinez, MD
Cannes hospital | Cannes, 06414, France Recruiting Fabien Rolland, MD
Henri-Mondor hospital (APHP) | Créteil, 94010, France Recruiting Ala Covali-Noroc, MD
Institut Médical de Sologne Les Pins | Lamotte-Beuvron, 41600, France Recruiting Natacha Brunet-Amiot, MD
Le Havre Jacques Monod hospital | Montivilliers, 76290, France Recruiting Bouchra Lamia, Pr
Pitié Salpétrière hospital (APHP) | Paris, 75013, France Recruiting Capucine Morelot-Panzini, Pr
Bichat hospital | Paris, 75877, France Recruiting Gilles Jébrak, MD Gilles Jébrak, MD Principal Investigator
Saint-Nazaire hospital | Saint-Nazaire, 44600, France Recruiting Loïc Du Couëdic, MD
Location Countries

France

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov