Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypercapnic Response

Study Overview
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Brief Summary
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The objective of this study is to evaluate the clinical benefits of home mechanical ventilation associated to oxygen therapy in COPD patients with chronic respiratory failure (CRF) who develop hypercapnia and nocturnal respiratory acidosis secondary to oxygen administration. We will include clinically stable COPD patients with hypercapnic CRF who develop a nocturnal hypercapnic response to oxygen (PaCO2 increase on awakening, at night with oxygen, >10 mmHg respect to PaCO2 breathing room air and awake). Obstructive sleep apnoea syndrome (OSAS) will previously have been excluded. Patients will be admitted to the Pneumology ward where a nocturnal pulsioxymetry breathing oxygen therapy will be performed. Arterial blood gas samples will be taken at awakening (7AM). Patients who develop a hypercapnic response to oxygen will be randomised into 2 treatment groups: Oxygen therapy group Home mechanical ventilation plus oxygen therapy group Home mechanical ventilation will be performed with a bilevel pressure ventilator. Functional respiratory variables as well as quality of life and sleep at onset and after 6 months treatment will be compared. The principal outcome will be the evolution of arterial blood gases (PaCO2) between the two groups.

Official Title
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Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Develop Nocturnal Hypercapnic Response Associated to Oxygen Therapy

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Home mechanical ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly patients < 80 years old. COPD (ERS/ATS (FEV1 < 80%, FEV1/FVC < 70%, TLC > 80%)). Oxygen therapy indication (PaO2 < 55 mmHg or 55-59 associated to pulmonary arterial hypertension, chronic Cor Pulmonale, Chronic Heart failure, arrhythmias or polyglobulia). PaCO2 > 50 mm Hg. Clinically stable at least prior to one month. Hypercapnic response: increasing PaCO2 > 10 mmHg at 7 a.m after all night with oxygen compared with PaCO2 when awake and without oxygen therapy. Exclusion Criteria: Active smoker. Bronchiectasis or tuberculous after-effects. Chronic respiratory failure secondary to thorax cage or neuromuscular diseases. BMI > 35 kg/m2 OSAS. Locomotor system problems that disable 6 minutes walking test execution. Patients with tracheostomy. Other serious comorbidity (i.e chronic heart failure functional class > II NYHA, cancer or chronic renal failure that requires dialysis.

Ages Eligible for Study
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Maximum Age: 80 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: 1<br>Oxygen therapy group. | |
| Active Comparator: 2<br>Home mechanical ventilation plus oxygen therapy group. | Other: Home mechanical ventilation<br>* Home mechanical ventilation will be performed with a bilevel pressure ventilator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial pressure of CO2. | Follow up of its evolution comparing patients under O2 treatment and patients under O2 + non invasive ventilation treatment. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional respiratory tests. | Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV). | Six months | 
| Quality of life related to health | Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV). | 6 months | 
| Nocturnal hypoventilation (nocturnal pulseoxymetry) | Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nocturnal hypercapnic response to oxygen, Home mechanical ventilation, COPD