Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
Recruiting · NCT03890224 · Interventional (participants receive a specific treatment) · Lead sponsor: Clinact
View the official record on ClinicalTrials.gov →Interventions studied
home ventilators
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- 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
1 location listed.
- Groupe Hospitalier Pitié Salpêtrière-Charles Foix - Paris, Île-de-France Region, France