Treating COVID-19 With a Bidirectional Oxygenation Valve

TMC Health

Status: Completed

Conditions: Coronavirus Infection

Treatments: Device: bidirectional oxygenation mouthpiece

Study type: Interventional

Funder types: Other

Identifiers

NCT04326452

GO2 PEEP Study (Other Identifier)

COVID19PEEP2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Enrolled Subjects

Experimental group

Description:

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.

Treatment:

Device: bidirectional oxygenation mouthpiece