An interventional study of Home ventilator in Chronic Obstructive Pulmonary Disease and Hypercapnic Respiratory Failure, sponsored by University Hospital, Rouen. Recruiting at 4 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Long Term oxygen therapy is prescribed according to the guidelines
Home non invasive ventilation is prescribed with the following settings * PS mode * IPAP according to clinical and hemodynamic tolerance * EPAP according to air trapping * RR around 12/ min. * LOT for SaO2 \> 90% * Monitoring with capnometry for settings validation
Device: Home ventilator
acute hypercapnic respiratory failure episode
first episode of acute hypercapnic respiratory failure episode requiring hospitalization
Time frame: up to 24 months
acute hypercapnic respiratory failure episode rate
Time frame: up to 24 months
pulmonary function test
Time frame: at one month and every six months up to 24 months
Six Minute Walk Distance
Time frame: at one month and every six months up to 24 months
Quality of life
Time frame: at one month and every six months up to 24 months
Heart function
left and right heart function assessed using echocardiography
Time frame: at one month and every six months up to 24 months
Cost effectiveness
Time frame: at one month and every six months up to 24 months
mortality
Time frame: at one month and every six months up to 24 months
arterial blood gas
Time frame: at one month and every six months up to 24 months
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University Hospital, Rouen