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Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients

RecruitingNAAges 18 Years - anyAllClinact
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: 1. Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment; 2. 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; 3. BMI \> 35 kg/m2; 4. Sedative medication causing hypercapnia (\> 3 drugs or more than 20mg of morphine/day); 5. Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI\>30/h (French criteria); 6. Cognitive impairment that would prevent informed consent into the trial 7. Pregnancy; 8. Tobacco use \< 10 pack-year; 9. Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge; 10. Unstable coronary artery syndrome; 11. Age \<18 years; 12. Inability to comply with the protocol; 13. Expected survival\<12 months due to any situation other than COPD disease; 14. Duration of ICU stay\>10 days; 15. No affiliated to national health insurance; 16. Measure of legal protection (guardianship, wardship or judicial protection) for patients over the age of majority.
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What it tests

  • home ventilators
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Where

1 site
Groupe Hospitalier Pitié Salpêtrière-Charles Foix
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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