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| Name | Class |
|---|---|
| Tufts Medical Center | OTHER |
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The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA clearance for use in patients with respiratory difficulty. The investigators believe that the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. This will be a study in 14 patients with severe-to-very severe chronic obstructive lung disease (COPD) to assess their work of breathing while using the NIOV system as measured by esophageal and stomach pressures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIOV Ventilator | Experimental | Breathe NIOV Ventilator under various volume augmentation settings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathe NIOV Ventilator | Device | Portable, non invasive open ventilation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System | Calculated using the area of the transdiaphragmatic pressure for the duration of inspiration | 10 min |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min | Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min) | 10 Min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Hill, MD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | 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 |