Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
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.
By 2020, chronic obstructive pulmonary disease (COPD) is expected to be the 3rd leading cause
 of death in the world, especially in countries of middle to high income, like EU. Despite the
 improvements in survival by using acute non- invasive ventilation (NIV) to treat patients
 with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these
 patients are at high risk of re-admission and further life-threatening events. Furthermore,
 in a recent study of 110 patients who had AHRF (RESCUE study, Struik, Thorax 2014), at one
 year after discharge 65% had another life-threatening event, and 49% had died. New recent
 data suggests that NIV at home can reduce re-admissions (HMV-LTOT, Murphy, JAMA 2017), but in
 a small proportion of patients, and with a high level of expertise. There is an urgent need
 to develop strategies to reduce the number and severity of exacerbations of COPD. With
 healthcare objectives and budget constraints, telemonitoring of COPD patients is an important
 challenge in most European countries. RESCUE2-Monitor is the next step. This European trial
 (currently, France, Spain and Portugal) will test the hypothesis that home NIV, with a highly
 adapted ventilatory strategy (hereafter referred to as 'TARGETED VENTILATION'), compared to
 no home NIV (only hospital NIV), to non-targeted home NIV or to rescue home NIV will reduce
 re-admission to hospital or death in COPD patients, is possible using e-medicine, and will
 reduce costs of health.
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.