Phase
Condition
N/ATreatment
home ventilators
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1)<65%;
- AHRF (pH<7,35 and PaCO2≥45mm Hg (≥6kPa) treated more than 24h with Ventilation (non-invasive or invasive);
- 48h to 2 weeks with pH>7.35, and PaCO2>45 (>6kPa) after NIV withdrawal, duringdaytime at rest without oxygen or ventilatory support (or with O2 if patientsare not able to avoid O2 with immediate desaturation below 80%).
Exclusion
Exclusion Criteria:
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. obesityhypoventilation and chest wall disease, however these patients will be included ifthe "FEV1/Forced vital capacity (FVC)" ratio is <60% and the FEV1 <50% if thepredominant defect is considered to be obstructive by the center clinician;
BMI > 35 kg/m2;
Sedative medication causing hypercapnia (> 3 drugs or more than 20mg ofmorphine/day);
Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI>30/h (Frenchcriteria);
Cognitive impairment that would prevent informed consent into the trial
Pregnancy;
Tobacco use < 10 pack-year;
Psychiatric disease necessitating anti-psychotic medication, ongoing treatment fordrug or alcohol addiction, persons of no fixed abode post-discharge;
Unstable coronary artery syndrome;
Age <18 years;
Inability to comply with the protocol;
Expected survival<12 months due to any situation other than COPD disease;
Duration of ICU stay>10 days;
No affiliated to national health insurance;
Measure of legal protection (guardianship, wardship or judicial protection) forpatients over the age of majority.
Study Design
Study Description
Connect with a study center
Groupe Hospitalier Pitié Salpêtrière-Charles Foix
Paris, Ile-de-France 75651
FranceActive - Recruiting

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