A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device

Study Overview
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Brief Summary
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Evaluate subjects in an prospective observational study Subjects will be administered scientifically validated questionnaires Evaluate Quality Improvement and Oxygen Utilization Improvements. 1. Functional capability, dyspnea, oxygen saturation as primary endpoints Baseline Dyspnea Index (BDI) Transitional Dyspnea Index (TDI) Chronic Respiratory Disease Questionnaire (CRQ) Six minute walk distance (6MWD) Oxygen saturation using pulse oximeter The secondary endpoints: Portable oxygen source utilization Health care utilization (emergency room encounters, hospital admissions)

Detailed Description
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Evaluate subjects in an prospective observational study in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine Quality Improvements through using the Breath Responsive Variable Bolus Oxygen Conserving Device with a Portable/Ambulatory Oxygen Source on improvements in functional capability, dyspnea, oxygen saturation, quality of life as primary endpoints, and portable oxygen source utilization, health care utilization as secondary endpoints.

Official Title
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A Study to Evaluate Improvement in the Quality of Life and Health and Economic Outcomes of Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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COPD

Intervention / Treatment
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* Device: Breath Responsive Variable Bolus Oxygen Conserving Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of chronic obstructive pulmonary disease (COPD) Clinically stable disease at the time of consent Current prescription of oxygen 24 hours a day Previous or current oximetry desaturation at rest or activity (≤88% on one occasion) Highest measured FEV1, 70% predicted; and Highest measured FEV1/FVC, 70% predicted Capable of giving informed consent Currently using a portable oxygen source that is a portable tank Mobility without a walker, cane or rollator Spo2 ≥ 90% on portable oxygen source at rest and activity Non-smoker at time of consent Exclusion Criteria: Cardiovascular disease - New York Heart Association Functional Class III Degenerative bone or joint disease with limited functional ability Current homeless persons Active drug/alcohol dependence Recent drug or alcohol abuse history within the past two years Clinically unstable at the time of consent Currently a tobacco smoker

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Obstructive Pulmonary Disease<br>More than 12 million adults are diagnosed with COPD COPD is the 3rd leading cause of death in the U.S. Breathing difficulty is the major reason patients seek medical attention COPD patients requiring hospitalization are associated with higher costs Oximetry is an important tool for assessing need for Long-Term Oxygen Therapy LTOT has been proven to improve survival and quality of life Patients provided with a breath responsive variable bolus oxygen conserving device: support increased activity improve quality of life increase functional capability reduce portable oxygen source utilization maintain and/or improve oxygen saturation | Device: Breath Responsive Variable Bolus Oxygen Conserving Device<br>* Mini Electronic Oxygen Conserving Device<br>* Other names: SmartDose®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Dyspnea Index (BDI) | Baseline Functional Capability, Dyspnea as measured with the Baseline Dyspnea Index (BDI) | At baseline once upon entry into the study | 
| Transition Dyspnea Index (TDI) | Improvement in Functional Capability, Dyspnea as measured with the Transition Dyspnea Index (TDI) | Every two weeks after baseline up to three months | 
| Chronic Respiratory Disease Questionnaire (CRQ) | Improvement in Quality of Life as measured with the Chronic Respiratory Disease Questionnaire | At baseline upon study entry and change from baseline every two weeks up to three months | 
| Oxygen Saturation | Assess pulse oximetry saturation at baseline on setting to maintain oxygen saturation equal to or greater than 90% at rest and with activity every two weeks to determine improvement or equivalence | At baseline upon study entry and change from baseline every two weeks up to three months | 
| Six Minute Walk Distance | Assess distance covered in meters at baseline over 6 minutes and every two weeks up to three months to determine improvement in functional capability | At baseline upon study entry and change from baseline every two weeks up to three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Portable Oxygen Source Utilization | Reduction in Portable Oxygen Source Use from baseline on enrollment with assessments of use each day throughout study period to determine if there are utilization reductions resulting in cost savings during study period. | 6 Months | 
| Healthcare Utilization | Unscheduled Hospital, Emergency Room or Physician Office Visits, as measured from baseline 6 months prior to study entry and during study period to identify utilization changes if any. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, LTOT, Long-Term Oxygen Therapy, Oxygen Conserving Device, Quality of Life, Six Minute Walk Distance, Portable Oxygen Source, Oxygen Saturation, Breath Responsive Variable Bolus Oxygen Conserving Device, BRVB-OCD, Pulse Oximetry