Home ventilation for COPD patients

Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support

This study is testing if different types of home breathing support can help COPD patients who have trouble breathing after a hospital stay avoid going back to the hospital and live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Clinact (Academic / other)
• Locations: 1 site (Paris, Île-de-France Region)
• Trial ID: NCT03890224 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of three different modalities of home non-invasive ventilation (NIV) compared to no home NIV in reducing hospital readmissions and mortality in COPD patients who experience acute hypercapnic respiratory failure. The trial aims to determine if a targeted ventilation strategy can improve patient outcomes and reduce healthcare costs through telemonitoring. Conducted across France, Spain, and Portugal, the study will enroll patients who have recently been treated for exacerbations of COPD and are persistently hypercapnic after NIV withdrawal.

Who should consider this trial

Good fit: Ideal candidates are COPD patients with severe airflow limitation and a history of acute hypercapnic respiratory failure.

Not a fit: Patients currently using chronic NIV or those with restrictive lung diseases causing hypercapnia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce hospital readmissions and mortality rates in COPD patients.

How similar studies have performed: Previous studies have shown promising results with home NIV in reducing readmissions, but this specific approach is novel.

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.

Where this trial is running

Paris, Île-de-France Region

• Groupe Hospitalier Pitié Salpêtrière-Charles Foix — Paris, Île-de-France Region, France (Recruiting)

Study contacts

• Principal investigator: Jesus Gonzalez, MD — Hôpital Pitié Salpêtrière-Charles Foix, Paris, France ,
• Study coordinator: Angèle Guilbot

Conditions Chronic Obstructive Pulmonary Disease; COPD Exacerbation; Respiratory Support