Coronavirus Infection
Conditions
Brief summary
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
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.
Interventions
DEVICEbidirectional oxygenation mouthpiece
Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.
Sponsors
PEEP Medical, LLC
TMC HealthCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse oximetry level | Change from Baseline pulse oximetry level at 15 minutes post treatment | The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Change from Baseline clinical measurements at 15 minutes post treatment | Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide. |
Countries
United States
Outcome results
None listed