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| ID | Type | Description | Link |
|---|---|---|---|
| GO2 PEEP Study | Other Identifier | GO2 Devices |
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| Name | Class |
|---|---|
| PEEP Medical, LLC | INDUSTRY |
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This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.
We have developed a simple and straightforward silicone rubber-made oral appliance that promotes positive expiratory airway pressures with the potential to enhance respiratory function while preventing and reversing atelectasis and hypoxia. The purpose of this study is to compare the use of our bidirectional oxygenation mouthpiece with conventional oxygen support versus conventional oxygen support of any Person Under Investigation for infection by the COVID-19 virus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled Subjects | Experimental | The purpose of this study is to compare the use of our bidirectional oxygenation mouthpiece with conventional oxygen support versus conventional oxygen support of any Person Under Investigation for infection by the COVID-19 virus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bidirectional oxygenation mouthpiece | Device | Use of our bidirectional oxygenation mouthpiece with conventional oxygen support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulse oximetry level | The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve | Change from Baseline pulse oximetry level at 15 minutes post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory rate | Change from Baseline clinical measurements at 15 minutes post treatment | |
| Heart rate | Change from Baseline clinical measurements at 15 minutes post treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TMC HealthCare | Tucson | Arizona | 85712 | United States | ||
| Stanford University |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Blood pressure |
| Change from Baseline clinical measurements at 15 minutes post treatment |
| Systemic carbon dioxide | Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide. | Change from Baseline clinical measurements at 15 minutes post treatment |
| Stanford |
| California |
| 94305 |
| United States |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| D007239 |
| Infections |