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

COPD Clinical Trial

— BRVB-OCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627599
• Other study ID #: 01012015DM
• Status: Completed
• Start date: May 2015
• Est. completion date: November 2016

Study information

• Verified date: August 2018
• Source: StratiHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• 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

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Breath Responsive Variable Bolus Oxygen Conserving Device
Mini Electronic Oxygen Conserving Device

Locations

Country	Name	City	State
United States	KP Oceanside Medical Office Building	Oceanside	California
United States	Tcmc - Mob	Vista	California
United States	Pathway Medical Group	Westminster	California

Sponsors (3)

Lead Sponsor	Collaborator
StratiHealth	Kaiser Permanente, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (36)

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Hardinge M, Annandale J, Bourne S, Cooper B, Evans A, Freeman D, Green A, Hippolyte S, Knowles V, MacNee W, McDonnell L, Pye K, Suntharalingam J, Vora V, Wilkinson T; British Thoracic Society Home Oxygen Guideline Development Group; British Thoracic Socie — View Citation

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Langenhof S, Fichter J. Comparison of two demand oxygen delivery devices for administration of oxygen in COPD. Chest. 2005 Oct;128(4):2082-7. — View Citation

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Martí S, Pajares V, Morante F, Ramón MA, Lara J, Ferrer J, Güell MR. Are oxygen-conserving devices effective for correcting exercise hypoxemia? Respir Care. 2013 Oct;58(10):1606-13. doi: 10.4187/respcare.02260. Epub 2013 Mar 19. — View Citation

McCoy R. Oxygen-conserving techniques and devices. Respir Care. 2000 Jan;45(1):95-103; discussion 104. Review. — View Citation

Mecikalski M, Shigeoka JW. A demand valve conserves oxygen in subjects with chronic obstructive pulmonary disease. Chest. 1984 Nov;86(5):667-70. — View Citation

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Palwai A, Skowronski M, Coreno A, Drummond C, McFadden ER Jr. Critical comparisons of the clinical performance of oxygen-conserving devices. Am J Respir Crit Care Med. 2010 May 15;181(10):1061-71. doi: 10.1164/rccm.200910-1638OC. Epub 2010 Feb 4. — View Citation

Pertelle, VR, Oxygen Conserving Technologies: Device Variability and the Effect on Clinical Applications and Expected Outcomes: A White Paper, October 2015

Petty TL, Bliss PL. Ambulatory oxygen therapy, exercise, and survival with advanced chronic obstructive pulmonary disease (the Nocturnal Oxygen Therapy Trial revisited). Respir Care. 2000 Feb;45(2):204-11; discussion 211-3. — View Citation

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Roberts CM, Bell J, Wedzicha JA. Comparison of the efficacy of a demand oxygen delivery system with continuous low flow oxygen in subjects with stable COPD and severe oxygen desaturation on walking. Thorax. 1996 Aug;51(8):831-4. — View Citation

Senn S, Wanger J, Fernandez E, Cherniack RM. Efficacy of a pulsed oxygen delivery device during exercise in patients with chronic respiratory disease. Chest. 1989 Sep;96(3):467-72. — View Citation

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Dyspnea Index (BDI)	Baseline Functional Capability, Dyspnea as measured with the Baseline Dyspnea Index (BDI)	At baseline once upon entry into the study
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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