Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure
Conditions
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).
Interventions
DEVICENon Invasive Ventilation
NIV during night
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute hypercapnic respiratory failure episode | up to 102 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Death | 1 month and every 6 months during 2 years |
Countries
France
Outcome results
None listed