Home Non-invasive Ventilation Versus Long-term Oxygen Therapy in COPD Survivors of Acute Hypercapnic Respiratory Failure. A Multicenter Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- University Hospital, Rouen
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Acute hypercapnic respiratory failure episode
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed to treat acute respiratory failure but little information is available about the benefits of home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure surviving an acute hypercapnic respiratory failure. The purpose of this study is to determine whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an episode of acute hypoxemic respiratory failure (AHRF) treated by Non-invasive ventilation (NIV).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years old
- •COPD patients who survived after an episode of acute hypercapnic respiratory failure
- •Patients weaned from ventilation (non invasive ventilation or mechanical ventilation) for acute episode since at least seven days with stable arterial blood gas since at least two days: PaCO2 \> 55 mmHg and pH \> 7.35
Exclusion Criteria
- •Age \> 85 years old
- •Non- COPD causes of respiratory failure
- •Obstructive sleep apnea excluded by polysomnography
- •Adverse psychosocial status
- •Serious co-morbidity
Outcomes
Primary Outcomes
Acute hypercapnic respiratory failure episode
Time Frame: up to 102 weeks
Secondary Outcomes
- Death(1 month and every 6 months during 2 years)