Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure
Conditions
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.
Interventions
DEVICEHome ventilator
Sponsors
ADIR Association
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute hypercapnic respiratory failure episode | up to 24 months | first episode of acute hypercapnic respiratory failure episode requiring hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| acute hypercapnic respiratory failure episode rate | 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 | — |
| Heart function | at one month and every six months up to 24 months | left and right heart function assessed using echocardiography |
Countries
France
Contacts
Primary ContactBouchra Lamia, MD, MPH, PhD
Outcome results
None listed