BRVB-OCD: A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device
Study Details
Study Description
Brief Summary
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Evaluate subjects in an prospective observational study
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Subjects will be administered scientifically validated questionnaires
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Evaluate Quality Improvement and Oxygen Utilization Improvements.
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Functional capability, dyspnea, oxygen saturation as primary endpoints
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Baseline Dyspnea Index (BDI)
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Transitional Dyspnea Index (TDI)
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Chronic Respiratory Disease Questionnaire (CRQ)
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Six minute walk distance (6MWD)
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Oxygen saturation using pulse oximeter
- The secondary endpoints:
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Portable oxygen source utilization
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Health care utilization (emergency room encounters, hospital admissions)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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: 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
Mini Electronic Oxygen Conserving Device
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Baseline Dyspnea Index (BDI) [At baseline once upon entry into the study]
Baseline Functional Capability, Dyspnea as measured with the Baseline Dyspnea Index (BDI)
- Transition Dyspnea Index (TDI) [Every two weeks after baseline up to three months]
Improvement in Functional Capability, Dyspnea as measured with the Transition Dyspnea Index (TDI)
- Chronic Respiratory Disease Questionnaire (CRQ) [At baseline upon study entry and change from baseline every two weeks up to three months]
Improvement in Quality of Life as measured with the Chronic Respiratory Disease Questionnaire
- Oxygen Saturation [At baseline upon study entry and change from baseline every two weeks up to three months]
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
- Six Minute Walk Distance [At baseline upon study entry and change from baseline every two weeks up to three months]
Assess distance covered in meters at baseline over 6 minutes and every two weeks up to three months to determine improvement in functional capability
Secondary Outcome Measures
- Portable Oxygen Source Utilization [6 Months]
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.
- Healthcare Utilization [6 Months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primary diagnosis of chronic obstructive pulmonary disease (COPD)
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Clinically stable disease at the time of consent
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Current prescription of oxygen 24 hours a day
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Previous or current oximetry desaturation at rest or activity (≤88% on one occasion)
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Highest measured FEV1, 70% predicted; and
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Highest measured FEV1/FVC, 70% predicted
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Capable of giving informed consent
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Currently using a portable oxygen source that is a portable tank
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Mobility without a walker, cane or rollator
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Spo2 ≥ 90% on portable oxygen source at rest and activity
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Non-smoker at time of consent
Exclusion Criteria:
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Cardiovascular disease - New York Heart Association Functional Class III
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Degenerative bone or joint disease with limited functional ability
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Current homeless persons
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Active drug/alcohol dependence
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Recent drug or alcohol abuse history within the past two years
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Clinically unstable at the time of consent
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Currently a tobacco smoker
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | KP Oceanside Medical Office Building | Oceanside | California | United States | 92054 |
| 2 | Tcmc - Mob | Vista | California | United States | 92054 |
| 3 | Pathway Medical Group | Westminster | California | United States | 92683 |
Sponsors and Collaborators
- StratiHealth
- Kaiser Permanente
- University of Pennsylvania
Investigators
- Principal Investigator: Isabel Pereira, MD, StratiHealth
Study Documents (Full-Text)
None provided.More Information
Publications
- Carter R, Tashkin D, Djahed B, Hathaway E, Nicotra MB, Tiep BL. Demand oxygen delivery for patients with restrictive lung disease. Chest. 1989 Dec;96(6):1307-11.
- Domingo C, Roig J, Coll R, Klamburg J, Izquierdo J, Ruiz-Manzano J, Morera J, Domingo E. Evaluation of the use of three different devices for nocturnal oxygen therapy in COPD patients. Respiration. 1996;63(4):230-5.
- Gould GA, Scott W, Hayhurst MD, Flenley DC. Technical and clinical assessment of oxygen concentrators. Thorax. 1985 Nov;40(11):811-6.
- Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87.
- Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38.
- Moore-Gillon JC, George RJ, Geddes DM. An oxygen conserving nasal cannula. Thorax. 1985 Nov;40(11):817-9.
- NAUGHTON J, SEVELIUS G, BALKE B. PHYSIOLOGICAL RESPONSES OF NORMAL AND PATHOLOGICAL SUBJECTS TO A MODIFIED WORK CAPACITY TEST. J Sports Med Phys Fitness. 1963 Dec;3:201-7.
- Rinow ME, Saltzman AR. Effectiveness of a new oxygen demand valve in chronic hypoxemia. Chest. 1986 Aug;90(2):204-7.
- Tiep BL, Nicotra MB, Carter R, Phillips R, Otsap B. Low-concentration oxygen therapy via a demand oxygen delivery system. Chest. 1985 May;87(5):636-8.
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