Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT03890224 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2024-06-20
Summary
The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV.
Conditions
- Chronic Obstructive Pulmonary Disease
- COPD Exacerbation
Interventions
- DEVICE
-
home ventilators
The 3 test treatments are home non-targeted NIV, home targeted NIV and rescue home NIV. COPD patients will be equipped with home ventilators and fitted with either nasal, oronasal or facial masks. All the ventilators used will be CE marked.
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
collaborator OTHER -
Fondation du Souffle
collaborator UNKNOWN -
Clinact
lead OTHER
Principal Investigators
-
Jesus Gonzalez, MD · Hôpital Pitié Salpêtrière-Charles Foix, Paris, France ,
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-04
- Primary Completion
- 2024-06-15
- Completion
- 2027-02-28
Countries
- France
Study Locations
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