Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinact
About this trial
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 criteria
Qualifiers
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%).
Disqualifiers
Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment;
Primary diagnosis of restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the "FEV1/Forced vital capacity (FVC)" ratio is <60% and the FEV1 <50% if the predominant defect is considered to be obstructive by the center clinician;
BMI > 35 kg/m2;
Sedative medication causing hypercapnia (> 3 drugs or more than 20mg of morphine/day);
Trial design
Treatments tested in this trial
- home ventilators
Treatment groups
400 Participants
are divided into 4 treatment groupsSponsors and collaborators
Clinact
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborator
Fondation du Souffle
Collaborator
Source ClinicalTrials.gov