A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device (BRVB-OCD)

StratiHealth

Status: Completed

Conditions: COPD

Treatments: Device: Breath Responsive Variable Bolus Oxygen Conserving Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02627599

01012015DM

Details and patient eligibility

About

• 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
  2. Baseline Dyspnea Index (BDI)
  3. Transitional Dyspnea Index (TDI)
  4. Chronic Respiratory Disease Questionnaire (CRQ)
  5. Six minute walk distance (6MWD)
  6. Oxygen saturation using pulse oximeter

• The secondary endpoints:

  1. Portable oxygen source utilization
  2. Health care utilization (emergency room encounters, hospital admissions)

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

35 participants in 1 patient group

Chronic Obstructive Pulmonary Disease

Description:

* 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

Treatment:

Device: Breath Responsive Variable Bolus Oxygen Conserving Device