NCT03890224Recruiting
Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support
Source: ClinicalTrials.gov · Last updated 20 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 15 Mar 2019
- Start date
- 4 Jul 2019
- Primary completion date
- 15 Jun 2024
- Lead sponsor
- Clinact
- Diseases
- COPD
- NCT number
- NCT03890224
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 4 Jul 2019 to the primary completion date, 15 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
Other illness
- 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
- Age \<18 years;
- Measure of legal protection (guardianship, wardship or judicial protection) for patients over the age of majority.
Other
- 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;
Who the study is looking for
- 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%).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Groupe Hospitalier Pitié Salpêtrière-Charles Foix Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.