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| Name | Class |
|---|---|
| ROX Medical, Inc. | INDUSTRY |
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The aim of this study is to investigate the six-minute-walking-distance of COPD-patients with breathing oxygen in comparison to breathing normal air. Patients, who increase their walking-distance about more than 15% or 35m only because of breathing oxygen, are so-called "Oxygen Responders." The study is aimed to find attributes of Oxygen Responder and to investigate, if a patient can change the "respond" with higher performance and endurance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First of 2 6-minute-walking test with oxygen | Other | Continuous flow of 2 liters per minute First with oxygen, second with medical air |
|
| First of 2 6-minute-walking tests with medical air | Other | Medical air is compressed room air. First test with medical air, second with oxygen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6MWT with oxygen | Other | 2 liter per minute as continuous-flow |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Response | Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks | day 1 and day 2; day 21 and day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | day 1: minute "0" and "6" |
| Diffusion Capacity | change in diffusion capacity from baseline to 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Kenn, Dr.med. | Klinikum Berchtesgadener Land, Schön Kliniken | Study Director |
| Inga Heinzelmann, Dipl. Sportw | Klinikum Berchtesgadener Land, Schön Kliniken | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Berchtesgadener Land, Schön Kliniken | Schönau am Königssee | 83471 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27940278 | Derived | Jarosch I, Gloeckl R, Damm E, Schwedhelm AL, Buhrow D, Jerrentrup A, Spruit MA, Kenn K. Short-term Effects of Supplemental Oxygen on 6-Min Walk Test Outcomes in Patients With COPD: A Randomized, Placebo-Controlled, Single-blind, Crossover Trial. Chest. 2017 Apr;151(4):795-803. doi: 10.1016/j.chest.2016.11.044. Epub 2016 Dec 8. |
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inpatient rehabilitation programme, recruitment directly after admission.
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| ID | Title | Description |
|---|---|---|
| FG000 | 6MWT With Different Gas Mixtures |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 6MWT With Different Gas Mixtures |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Oxygen Response | Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks | per protocol | Posted | Mean | Standard Deviation | Meter | day 1 and day 2; day 21 and day 22 |
|
|
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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 | 6MWT With Different Gas Mixtures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Klaus Kenn | Schön Klinik BGL | 0865293 | 1540 | iheinzelmann@schoen-kliniken.de |
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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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| ID | Term |
|---|---|
| D010100 | Oxygen |
| D000388 | Air |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D001272 |
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| 6MWT with medical air | Other | 2 liters as continuous-flow |
|
| day 1 and 21 |
| Lung Function | change in lung function from baseline to 3 weeks | day 1 and 21 |
| BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | day 1: minute 0 and minute 6 |
| Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | day 1: minute 0 and 6 |
| Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | day 21: minute 0 and minute 6 |
| BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | day 2: minute 0 and minute 6 |
| BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | day 22: minute 0 and minute 6 |
| BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | day 21: minute 0 and minute 6 |
| Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | day 20: minute 0 and minute 6 |
| Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | day 2: minute "0" and "6" |
| Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | day 2: minute 0 and 6 |
| Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | day 21: minute 0 and 6 |
| Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | day 22: minute 0 and 6 |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Forced expiratory volume in 1 second (FEV1%pred.) | in percentage of predicted value | Mean | Standard Deviation | percentage of predicted value |
|
|
| Secondary | Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | Not Posted | day 1: minute "0" and "6" |
| Secondary | Diffusion Capacity | change in diffusion capacity from baseline to 3 weeks | Not Posted | day 1 and 21 |
| Secondary | Lung Function | change in lung function from baseline to 3 weeks | Not Posted | day 1 and 21 |
| Secondary | BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | Not Posted | day 1: minute 0 and minute 6 |
| Secondary | Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | Not Posted | day 1: minute 0 and 6 |
| Secondary | Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | Not Posted | day 21: minute 0 and minute 6 |
| Secondary | BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | Not Posted | day 2: minute 0 and minute 6 |
| Secondary | BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | Not Posted | day 22: minute 0 and minute 6 |
| Secondary | BORG-Score | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air | Not Posted | day 21: minute 0 and minute 6 |
| Secondary | Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | Not Posted | day 20: minute 0 and minute 6 |
| Secondary | Oxygen Partial Pressure (paO2) | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air | Not Posted | day 2: minute "0" and "6" |
| Secondary | Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | Not Posted | day 2: minute 0 and 6 |
| Secondary | Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | Not Posted | day 21: minute 0 and 6 |
| Secondary | Oxygen Saturation | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air | Not Posted | day 22: minute 0 and 6 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |