Home breathing machines for COPD patients after a flare-up
Tests home breathing machines in adults with COPD after a flare-up.
Plain-language title generated from the registry record
Registry title: Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
Key facts
- Where
- Paris, FranceSee the site
Where in France
- Groupe Hospitalier Pitié Salpêtrière-Charles FoixParis, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Clinact
- Trial code
- NCT03890224
- Record updated
- 20 June 2024
- Original description
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.Read full original descriptionShow less
Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support
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.
Inclusion: 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%).
Exclusion: Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment; Sedative medication causing hypercapnia (> 3 drugs or more than 20mg of morphine/day); 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; Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI>30/h (French criteria); Cognitive impairment that would prevent informed consent into the trial; Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge; Unstable coronary artery syndrome; Expected survival<12 months due to any situation other than COPD disease; Age <18 years; Measure of legal protection (guardianship, wardship or judicial protection) for patients over the age of majority; BMI > 35 kg/m2; Pregnancy; Tobacco use < 10 pack-year; Inability to comply with the protocol; Duration of ICU stay>10 days; No affiliated to national health insurance.