Treating COVID-19 With a Bidirectional Oxygenation Valve
Purpose
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.
Condition
- Coronavirus Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Oxygen saturation <93% - Able to provide informed consent - Not currently requiring intubation - Receiving oxygen by face mask
Exclusion Criteria
- Unable or unwilling to provide informed consent, cognitive impairment - Rapidly decompensating status requiring urgent or emergent higher level of care
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Enrolled Subjects |
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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04326452
- Status
- Completed
- Sponsor
- TMC HealthCare
Detailed Description
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.