Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 1\) Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1)\<65%;
• 2\) AHRF (pH\<7,35 and PaCO2≥45mm Hg (≥6kPa) treated more than 24h with Ventilation (non-invasive or invasive);
• 3\) 48h to 2 weeks with pH\>7.35, and PaCO2\>45 (\>6kPa) after NIV withdrawal, during daytime at rest without oxygen or ventilatory support (or with O2 if patients are not able to avoid O2 with immediate desaturation below 80%).
Locations
Other Locations
France
Groupe Hospitalier Pitié Salpêtrière-Charles Foix
RECRUITING
Paris
Contact Information
Primary
Angèle Guilbot
angele.guilbot@multihealthgroup.com
+33-180-13-15-19
Backup
Nathalie Gagne
nathalie.gagne@clinact.com
+33-180-13-14-70
Time Frame
Start Date: 2019-07-04
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 400
Treatments
No_intervention: Control group
no home non-invasive ventilation (NIV), only hospital NIV
Active_comparator: Non-targeted home NIV
Nocturnal home non-invasive ventilation (NIV)
Active_comparator: Targeted home NIV
Nocturnal home non-invasive ventilation (NIV) with high monitoring
Active_comparator: Rescue home NIV
home non-invasive ventilation (NIV) on demand
Related Therapeutic Areas
Sponsors
Leads: Clinact
Collaborators: Fondation du Souffle, Assistance Publique - Hôpitaux de Paris