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

NCT02627599 | Completed DMC

• 1 other identifier: 01012015DM
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 3

Brief 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
• Baseline Dyspnea Index (BDI)
• Transitional Dyspnea Index (TDI)
• Chronic Respiratory Disease Questionnaire (CRQ)
• Six minute walk distance (6MWD)
• Oxygen saturation using pulse oximeter
• The secondary endpoints:
• Portable oxygen source utilization
• Health care utilization (emergency room encounters, hospital admissions)

Conditions

COPD

Keywords

COPD; LTOT; Long-Term Oxygen Therapy; Oxygen Conserving Device; Quality of Life; Six Minute Walk Distance; Portable Oxygen Source; Oxygen Saturation; Breath Responsive Variable Bolus Oxygen Conserving Device; BRVB-OCD; Pulse Oximetry

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (2)

• Portable Oxygen Source Utilization

  6 Months

• Healthcare Utilization

  6 Months

Study Arms (1)

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

Device: Breath Responsive Variable Bolus Oxygen Conserving Device

Interventions

Breath Responsive Variable Bolus Oxygen Conserving Device DEVICE

Mini Electronic Oxygen Conserving Device

Also known as: SmartDose®

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic Obstructive Pulmonary Disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• StratiHealth: lead
• Kaiser Permanente: collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

KP Oceanside Medical Office Building

Oceanside, California, 92054, United States

Location

Tcmc - Mob

Vista, California, 92054, United States

Location

Pathway Medical Group

Westminster, California, 92683, United States

Location

Related Publications (36)

• 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.

  PMID: 4071456 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.

  PMID: 8815970 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.

  PMID: 14099069 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.

  PMID: 9872837 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.

  PMID: 16055882 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.

  PMID: 2582836 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.

  PMID: 3731892 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.

  PMID: 3921316 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.

  PMID: 4071457 BACKGROUND

• 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.

  PMID: 16235285 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.

  PMID: 15219010 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.

  PMID: 22878278 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.

  PMID: 19245728 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.

  PMID: 15481269 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.

  PMID: 16236858 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.

  PMID: 10325901 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.

  PMID: 16381613 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.

  PMID: 2204507 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.

  PMID: 14744265 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.

  PMID: 12091180 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.

  PMID: 20133925 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.

  PMID: 2766806 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.

  PMID: 3383659 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.

  PMID: 3792073 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.

  PMID: 6488901 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.

  PMID: 8795673 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.

  PMID: 1516389 RESULT

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

  PMID: 10771785 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.

  PMID: 16710952 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.

  PMID: 6110912 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.

  PMID: 6776858 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.

  PMID: 25870317 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.

  PMID: 23513249 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.

  PMID: 10771792 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.

  PMID: 3608597 RESULT

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

  RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabel Pereira, MD

  StratiHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 11, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)