Home Non Invasive Ventilation for COPD Patients

Study Overview
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Brief Summary
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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.

Official Title
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Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial

Conditions
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Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: Home ventilator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Long Term Oxygen Therapy alone<br>Long Term oxygen therapy is prescribed according to the guidelines | |
| Active Comparator: Non invasive ventilation<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute hypercapnic respiratory failure episode | first episode of acute hypercapnic respiratory failure episode requiring hospitalization | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | left and right heart function assessed using echocardiography | 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 |