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Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients

RECRUITINGN/ASponsored by Clinact
Actively Recruiting
PhaseN/A
SponsorClinact
Started2019-07-04
Est. completion2024-06-15
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

COPDCOPD ExacerbationChronic Obstructive Pulmonary Disease

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