Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy

Study Overview
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Brief Summary
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The aim of this study is to investigate the efficacy of non-invasive ventilation (NIV) on nocturnal hypoventilation in patients with chronic obstructive pulmonary disease (COPD) who are on long term oxygen therapy (LTOT) at home.

Detailed Description
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This is a prospective, randomized, open labelled study. The primary outcome is nocturnal transcutaneous CO2 (PtCO2) after 3 months of non-invasive ventilation. Three hundred COPD patients on LTOT will be screened and assessed by pulmonary function tests, blood gases and nocturnal PtCO2 at their home. This will allow the determination of the prevalence of nocturnal hypoventilation in COPD patients on LTOT (a secondary outcome) and to select patients who meet the inclusion criteria for the RCT and randomization to NIV + LTOT or to continue LTOT alone (n=38). Patients will undergo the same assessments at the end of the three-month intervention period.

Official Title
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Non Invasive Ventilation and Nocturnal Alveolar Hypoventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated by Long Term Oxygen Therapy at Home

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: NIV Device + LTOT
* Device: LTOT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic obstructive pulmonary disease (COPD) on long term oxygen therapy (LTOT) affiliated to French social security system or equivalent informed consent signed Exclusion Criteria: Diurnal PtCO2 >55mmHg Patient who has had an exacerbation of COPD requiring a change in management or treatment in the last 4 weeks prior to the inclusion visit. Pregnant or breathfeeding women Prisonners or persons who require protection by the law Exclusion period from another study Persons who, according to the investigator, are expected no to meet all study obligations

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 |
| --- | --- |
| Experimental: NIV Device + LTOT<br>administration of ventilary support, without using an invasive artificial airway | Device: NIV Device + LTOT<br>* Respiratory assistance by a facial mask without intubation or tracheotomy<br>|
| Active Comparator: LTOT<br>standard treatment, without NIV | Device: LTOT<br>* Long term oxygenatory tyherapy without NIV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal transcutaneous pressure CO2 (PtCO2) | Measurement of nocturnal PtCO2 using the SenTec system | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saint George's Respiratory Questionnaire | Measure of quality of life | 3 months | 
| FEV1 | Pulmonary function tests | 3 months | 
| Vital capacity | Pulmonary function tests | 3 months | 
| PaO2 | Blood gases | 3 months | 
| PaCO2 | Blood gases | 3 months | 
| Steps per day | Physical activity measured at home (one week) | 3 months | 
| Time in supine and sitting positions | Physical activity measured at home (one week) | 3 months | 
| Energy expenditure | Physical activity measured at home (one week) | 3 months | 
| Heart Rate | Physiological responses during the Semi paced 3-min Chair rise test | 3 months | 
| SaO2 | Physiological responses during the Semi paced 3-min Chair rise test | 3 months | 
| Dyspnea score | Symptoms during the Semi paced 3-min Chair rise test | 3 months | 
| Fatigue score | Symptoms during the Semi paced 3-min Chair rise test | 3 months | 
| Cholesterol | Biological parameters | 3 months | 
| Triglycerides | Biological parameters | 3 months | 
| Fasting Glucose | Biological parameters | 3 months | 
| CRPus | Biological parameters | 3 months | 
| HBA1c | Biological parameters | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Oxygenation Long term, Non invasive Ventilation, Nocturnal Hypoventilation