Loading clinical trials...
Loading clinical trials...
Assessment of the Home Non-invasive Compliance in Patients With Chronic Obstructive Pulmonary Disease Following the Introduction of Long-term Ventilation. An Observational Study
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Pays d'Aix hospital
Aix-en-Provence, France
Cannes hospital
Cannes, France
Henri-Mondor hospital (APHP)
Créteil, France
Institut Médical de Sologne Les Pins
Lamotte-Beuvron, France
Le Havre Jacques Monod hospital
Montivilliers, France
Pitié Salpétrière hospital (APHP)
Paris, France
Bichat hospital
Paris, France
Saint-Nazaire hospital
Saint-Nazaire, France
Start Date
December 16, 2019
Primary Completion Date
December 31, 2022
Completion Date
December 31, 2022
Last Updated
March 15, 2023
25
ACTUAL participants
Lead Sponsor
Vivisol
Collaborators
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions