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New treatment option for Chronic Obstructive Pulmonary Disease
Official title Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
ClinicalTrials.gov ID: NCT03890224
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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...
- 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
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Île-de-France Region, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.