Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
Recruiting now · Not applicable
Conditions studied: Chronic Obstructive Pulmonary Disease, COPD Exacerbation
In brief
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.
Key facts
- Study ID
- NCT03890224
- Run by
- Clinact
- People needed
- 400
- Starts
- 2019-07-04
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2024-06-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%).
You may not qualify if…
- 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);
- Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI>30/h (French criteria);
- Cognitive impairment that would prevent informed consent into the trial
- Pregnancy;
- Tobacco use < 10 pack-year;
- Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug 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) for patients over the age of majority.
Where it is running
- Groupe Hospitalier Pitié Salpêtrière-Charles Foix — Paris, Île-de-France Region, France (enrolling)
Full record on ClinicalTrials.gov
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