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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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The study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. The study population will consist of severe Chronic Obstructive Pulmonary Disease (COPD) subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Feasibility | Experimental | Patients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback. |
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| Part 2: Crossover | Experimental | Crossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIR-AD | Device | Non-significant risk medical device as decided by institutional review board |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess distance travelled during 6-minute walk tests performed with and without device. | Distances travelled during two six minute walk tests will be measured. Investigator will compare distance travelled with use of the device to the distance travelled without the use of the device. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess for patient improvement in shortness of breath scores | This will be be measured via survey tool Borg Scale of Dyspnea (0 - no dyspnea, through 10 - maximal dyspnea). Patient scores will be measured during exercise testing with and without the device. Improvement will be considered a lower score on the Borg Scale. | 6 months |
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Inclusion Criteria:
1. Moderate to severe COPD (by ATS criteria)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Escobar | Contact | 215-349-5023 | escobarm@pennmedicine.upenn.edu | |
| Perry Dubin, MD/MPH | Contact | 6105172053 |
| Name | Affiliation | Role |
|---|---|---|
| John Hansen-Flaschen, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hansen-Flaschen | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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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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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |