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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| University of Pennsylvania | OTHER |
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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
The secondary endpoints:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Obstructive Pulmonary Disease |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath Responsive Variable Bolus Oxygen Conserving Device | Device | Mini Electronic Oxygen Conserving Device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic Obstructive Pulmonary Disease
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| Name | Affiliation | Role |
|---|---|---|
| Isabel Pereira, MD | StratiHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KP Oceanside Medical Office Building | Oceanside | California | 92054 | United States | ||
| Tcmc - Mob |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4071456 | Background | Gould GA, Scott W, Hayhurst MD, Flenley DC. Technical and clinical assessment of oxygen concentrators. Thorax. 1985 Nov;40(11):811-6. doi: 10.1136/thx.40.11.811. | |
| 8815970 | Background | 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. doi: 10.1159/000196550. |
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Results will be submitted for publication in peer review
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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 |
| Vista |
| California |
| 92054 |
| United States |
| Pathway Medical Group | Westminster | California | 92683 | United States |
| 14099069 | Background | 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. No abstract available. |
| 9872837 | Background | 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. doi: 10.1164/ajrccm.159.1.9712108. |
| 16055882 | Background | 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. doi: 10.1183/09031936.05.00034805. No abstract available. |
| 2582836 | Background | 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. doi: 10.1378/chest.96.6.1307. |
| 3731892 | Background | Rinow ME, Saltzman AR. Effectiveness of a new oxygen demand valve in chronic hypoxemia. Chest. 1986 Aug;90(2):204-7. doi: 10.1378/chest.90.2.204. |
| 3921316 | Background | 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. doi: 10.1378/chest.87.5.636. |
| 4071457 | Background | Moore-Gillon JC, George RJ, Geddes DM. An oxygen conserving nasal cannula. Thorax. 1985 Nov;40(11):817-9. doi: 10.1136/thx.40.11.817. |
| 16235285 | Result | Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD001744. doi: 10.1002/14651858.CD001744.pub2. |
| 15219010 | Result | Celli BR, MacNee W; ATS/ERS Task Force. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004 Jun;23(6):932-46. doi: 10.1183/09031936.04.00014304. No abstract available. |
| 22878278 | Result | Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9. |
| 19245728 | Result | Strickland SL, Hogan TM, Hogan RG, Sohal HS, McKenzie WN, Petroski GF. A randomized multi-arm repeated-measures prospective study of several modalities of portable oxygen delivery during assessment of functional exercise capacity. Respir Care. 2009 Mar;54(3):344-9. |
| 15481269 | Result | Fuhrman C, Chouaid C, Herigault R, Housset B, Adnot S. Comparison of four demand oxygen delivery systems at rest and during exercise for chronic obstructive pulmonary disease. Respir Med. 2004 Oct;98(10):938-44. doi: 10.1016/j.rmed.2004.03.010. |
| 16236858 | Result | Langenhof S, Fichter J. Comparison of two demand oxygen delivery devices for administration of oxygen in COPD. Chest. 2005 Oct;128(4):2082-7. doi: 10.1378/chest.128.4.2082. |
| 10325901 | Result | Garrod R, Bestall JC, Paul E, Wedzicha JA. Evaluation of pulsed dose oxygen delivery during exercise in patients with severe chronic obstructive pulmonary disease. Thorax. 1999 Mar;54(3):242-4. doi: 10.1136/thx.54.3.242. |
| 16381613 | Result | Gallegos LC, Shigeoka JW. Novel oxygen-concentrator-based equipment: take a test drive first! Respir Care. 2006 Jan;51(1):25-8. No abstract available. |
| 2204507 | Result | Jette M, Sidney K, Blumchen G. Metabolic equivalents (METS) in exercise testing, exercise prescription, and evaluation of functional capacity. Clin Cardiol. 1990 Aug;13(8):555-65. doi: 10.1002/clc.4960130809. |
| 14744265 | Result | Bliss PL, McCoy RW, Adams AB. Characteristics of demand oxygen delivery systems: maximum output and setting recommendations. Respir Care. 2004 Feb;49(2):160-5. |
| 12091180 | Result | ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. |
| 20133925 | Result | 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. |
| 2766806 | Result | 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. doi: 10.1378/chest.96.3.467. |
| 3383659 | Result | Bower JS, Brook CJ, Zimmer K, Davis D. Performance of a demand oxygen saver system during rest, exercise, and sleep in hypoxemic patients. Chest. 1988 Jul;94(1):77-80. doi: 10.1378/chest.94.1.77. |
| 3792073 | Result | Tiep BL, Carter R, Nicotra B, Berry J, Phillips RE, Otsap B. Demand oxygen delivery during exercise. Chest. 1987 Jan;91(1):15-20. doi: 10.1378/chest.91.1.15. |
| 6488901 | Result | Mecikalski M, Shigeoka JW. A demand valve conserves oxygen in subjects with chronic obstructive pulmonary disease. Chest. 1984 Nov;86(5):667-70. doi: 10.1378/chest.86.5.667. |
| 8795673 | Result | 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. doi: 10.1136/thx.51.8.831. |
| 1516389 | Result | Braun SR, Spratt G, Scott GC, Ellersieck M. Comparison of six oxygen delivery systems for COPD patients at rest and during exercise. Chest. 1992 Sep;102(3):694-8. doi: 10.1378/chest.102.3.694. |
| 10771785 | Result | McCoy R. Oxygen-conserving techniques and devices. Respir Care. 2000 Jan;45(1):95-103; discussion 104. |
| 16710952 | Result | Doherty DE, Petty TL, Bailey W, Carlin B, Cassaburi R, Christopher K, Kvale P, Make B, Mapel D, Selecky P, Tiger J. Recommendations of the 6th long-term oxygen therapy consensus conference. Respir Care. 2006 May;51(5):519-25. No abstract available. |
| 6110912 | Result | Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6. |
| 6776858 | Result | Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391. |
| 25870317 | Result | 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 Society Standards of Care Committee. British Thoracic Society guidelines for home oxygen use in adults. Thorax. 2015 Jun;70 Suppl 1:i1-43. doi: 10.1136/thoraxjnl-2015-206865. |
| 23513249 | Result | Marti S, Pajares V, Morante F, Ramon MA, Lara J, Ferrer J, Guell 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. |
| 10771792 | Result | 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. |
| 3608597 | Result | Tiep BL, Lewis MI. Oxygen conservation and oxygen-conserving devices in chronic lung disease. A review. Chest. 1987 Aug;92(2):263-72. doi: 10.1378/chest.92.2.263. |
| Result | Pertelle, VR, Oxygen Conserving Technologies: Device Variability and the Effect on Clinical Applications and Expected Outcomes: A White Paper, October 2015 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |