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Prospective randomized study with a cross-over design. Mobi™ is a relatively new POC in the market and thus it is valuable to collect data from COPD patients using supplemental oxygen, and their use on Mobi™. The purpose of the present study is to compare Mobi™ with a continuous flow oxygen cylinder, with SpO2 as the primary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portable oxygen cylinder | Active Comparator | Continuous flow oxygen cylinders will be used as a comparison. |
|
| Mobi™ Portable Oxygen Concentrator | Experimental | Mobi™ is indicated for patients who require supplemental oxygen, including COPD patients. It provides supplemental, high oxygen concentration to these patients. It is available via prescription only and may be used in the home, institution, and hospital settings, as well as travel environments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable Oxygen Cylinder | Device | A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs) | Each subject's SpO2 will be measured when each subject takes six minutes walk test | Mean Sp02, measured during 6 minute walk test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Clark, M.D | SleepData | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SleepData | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31404750 | Background | Gloeckl R, Jarosch I, Schneeberger T, Fiedler C, Lausen M, Weingaertner J, Hitzl W, Kenn K, Koczulla AR. Comparison of supplemental oxygen delivery by continuous versus demand based flow systems in hypoxemic COPD patients - A randomized, single-blinded cross-over study. Respir Med. 2019 Sep;156:26-32. doi: 10.1016/j.rmed.2019.08.001. Epub 2019 Aug 5. | |
| 18686732 |
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Participants acted as their own controls. Participants were randomised as to the order they used the devices during the 6-minute walking test. There was a one hour wash out period between tests
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| ID | Title | Description |
|---|---|---|
| FG000 | Portable Oxygen Cylinder, Then Mobi | Participants acted as their own control in this study. Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients |
| FG001 | Mobi, Then Portable Oxygen Cylinder | Participants acted as their own control in this study. Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Hour) |
| |||||||||||||
| Washout (One Hour) |
| |||||||||||||
| Second Intervention |
|
COPD adult patients with long term oxygen therapy history were included. They were all stable (at least 4 weeks since last exacerbation episode).
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants acted as their own control during this study. Participants used a portable oxygen cylinder whilst doing a 6 minute walking test. After a wash out period the participants completed the 6 minute walking test with the second portable oxygen cylinder. The order of the oxygen cylinders (mobi or standard) was randomised |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs) | Each subject's SpO2 will be measured when each subject takes six minutes walk test | Posted | Mean | Standard Error | percentage of oxygen saturation | Mean Sp02, measured during 6 minute walk test |
|
Adverse events were collected during the one study visit. After completion of this visit, the participants involvement in the study was completed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Oxygen Cylinder | Participants acted as their own control in this study. Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| maureen crocker | ResMed | +1 8588366653 | maureen.crocker@resmed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2020 | Mar 23, 2021 | Prot_SAP_000.pdf |
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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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This is a prospective, randomized, cross-over study design with participants serving as their own controls. A within- participants, repeated-measures design is used during 6MWT. Eligible participants will complete two 6MWTs: one with their usual portable oxygen cylinder, and one with Mobi™. All participants entered into the study will be randomized in a 1:1 ratio to the following order of device use:
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|
| Mobi | Device | ResMed's variant of POC |
|
|
| Guell Rous R. Long-term oxygen therapy: are we prescribing appropriately? Int J Chron Obstruct Pulmon Dis. 2008;3(2):231-7. doi: 10.2147/copd.s1230. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Mobi | Participants acted as their own control in this study. Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients | 0 | 33 | 0 | 33 | 0 | 33 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |