Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients

Launched by CLINACT · Mar 24, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating how different types of home breathing support, known as non-invasive ventilation (NIV), can help patients with Chronic Obstructive Pulmonary Disease (COPD) who have had a recent worsening of their condition. The goal is to see if using these home devices can reduce the chances of patients needing to go back to the hospital or facing serious health issues like death, compared to those who do not receive this home support after their hospital stay.

To be part of the study, patients need to be between 65 and 74 years old and have severe COPD (classified as GOLD C or D) with a specific level of lung function. They should have experienced a recent episode of respiratory failure that required ventilation support and are now stable but still have high levels of carbon dioxide in their blood. Participants can expect to receive either one of the three types of home NIV or standard care, and their health will be monitored closely throughout the trial. It's important to note that certain conditions or treatments may prevent someone from joining, like using a different type of breathing support or having issues that could complicate their participation.

Gender

ALL

Eligibility criteria

• 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.