A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device
NCT ID: NCT02627599
Last Updated: 2018-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2015-05-31
2016-11-30
Brief Summary
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* Subjects will be administered scientifically validated questionnaires
* Evaluate Quality Improvement and Oxygen Utilization Improvements.
1\. Functional capability, dyspnea, oxygen saturation as primary endpoints
1. Baseline Dyspnea Index (BDI)
2. Transitional Dyspnea Index (TDI)
3. Chronic Respiratory Disease Questionnaire (CRQ)
4. Six minute walk distance (6MWD)
5. Oxygen saturation using pulse oximeter
* The secondary endpoints:
1. Portable oxygen source utilization
2. Health care utilization (emergency room encounters, hospital admissions)
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chronic Obstructive Pulmonary Disease
* 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:
1. support increased activity
2. improve quality of life
3. increase functional capability
4. reduce portable oxygen source utilization
5. maintain and/or improve oxygen saturation
Breath Responsive Variable Bolus Oxygen Conserving Device
Mini Electronic Oxygen Conserving Device
Interventions
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Breath Responsive Variable Bolus Oxygen Conserving Device
Mini Electronic Oxygen Conserving Device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
85 Years
ALL
Yes
Sponsors
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Kaiser Permanente
OTHER
University of Pennsylvania
OTHER
StratiHealth
INDUSTRY
Responsible Party
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Principal Investigators
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Isabel Pereira, MD
Role: PRINCIPAL_INVESTIGATOR
StratiHealth
Locations
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KP Oceanside Medical Office Building
Oceanside, California, United States
Tcmc - Mob
Vista, California, United States
Pathway Medical Group
Westminster, California, United States
Countries
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References
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Other Identifiers
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01012015DM
Identifier Type: -
Identifier Source: org_study_id
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