Treating COVID-19 With a Bidirectional Oxygenation Valve

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection

Conditions
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Coronavirus Infection

Intervention / Treatment
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* Device: bidirectional oxygenation mouthpiece


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enrolled Subjects<br>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. | Device: bidirectional oxygenation mouthpiece<br>* Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |