Home ventilation for COPD patients
Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial
NA · University Hospital, Rouen · NCT03221101
This study is testing if using a home ventilator can help people with COPD who have had serious breathing problems avoid future episodes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Rouen (other) |
| Locations | 4 sites (Dieppe and 3 other locations) |
| Trial ID | NCT03221101 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term effects of home non-invasive ventilation on patients with Chronic Obstructive Pulmonary Disease (COPD) who have previously experienced acute hypercapnic respiratory failure. It aims to determine if using a home ventilator can reduce the incidence of recurrent acute episodes in these patients. The study focuses on individuals who have been weaned off ventilation after an acute episode and have specific arterial blood gas parameters. By assessing the outcomes of home ventilation, the study seeks to provide insights into improving patient care and management.
Who should consider this trial
Good fit: Ideal candidates for this study are COPD patients who have survived an acute hypercapnic respiratory failure episode and have been weaned from ventilation for at least five days.
Not a fit: Patients with severe obstructive sleep apnea, non-COPD related respiratory failure, serious comorbidities, or adverse psychological status may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency of acute respiratory failure episodes in COPD patients, improving their quality of life.
How similar studies have performed: While few studies have explored the long-term benefits of home non-invasive ventilation in this specific patient population, existing evidence suggests potential benefits in acute settings, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * COPD patients who survived after an acute episode of hypercapnic respiratory failure * patients weaned from ventilation ( non invasive ventilation or mechanical ventilation) prescribed for acute episode since at least five days with following arterial blood gas : pH \> 7.35 and PCO2 \> = 45 mmHg Exclusion Criteria: * severe obstructive sleep apnea ( DI \> 30/h) * Non COPD cause of respiratory failure * Serious comorbidity * Adverse psychological status
Where this trial is running
Dieppe and 3 other locations
- CH Dieppe — Dieppe, France (RECRUITING)
- CH Elbeuf — Elbeuf, France (RECRUITING)
- Le Havre, Jacques Monod Hospital — Montivilliers, France (RECRUITING)
- CHU de Rouen — Rouen, France (RECRUITING)
Study contacts
- Study coordinator: Bouchra Lamia, MD, MPH, PhD
- Email: bouchra.lamia@chu-rouen.fr
- Phone: 0685426884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure