Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- University Hospital, Rouen
- Enrollment
- 86
- Locations
- 4
- Primary Endpoint
- acute hypercapnic respiratory failure episode
- Status
- Recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. 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 acute hypercapnic respiratory failure episode treated by non invasive ventilation.
Investigators
BOUCHRA LAMIA
Professor of medecine, pulmonology. MD, MPH, PhD
University Hospital, Rouen
Eligibility 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
Outcomes
Primary Outcomes
acute hypercapnic respiratory failure episode
Time Frame: up to 24 months
first episode of acute hypercapnic respiratory failure episode requiring hospitalization
Secondary Outcomes
- acute hypercapnic respiratory failure episode rate(up to 24 months)
- pulmonary function test(at one month and every six months up to 24 months)
- Six Minute Walk Distance(at one month and every six months up to 24 months)
- Quality of life(at one month and every six months up to 24 months)
- Heart function(at one month and every six months up to 24 months)
- Cost effectiveness(at one month and every six months up to 24 months)
- mortality(at one month and every six months up to 24 months)
- arterial blood gas(at one month and every six months up to 24 months)