Treating COVID-19 With a Bidirectional Oxygenation Valve

Completed · Not applicable

Conditions studied: Coronavirus Infection

In brief

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.

Key facts

Study ID

NCT04326452

Run by

TMC HealthCare

People needed

10

Starts

2020-03-27

Expected to finish

2021-03-27

Last updated by the study team

2022-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Oxygen saturation <93%
• Able to provide informed consent
• Not currently requiring intubation
• Receiving oxygen by face mask

You may not qualify if…

• Unable or unwilling to provide informed consent, cognitive impairment
• Rapidly decompensating status requiring urgent or emergent higher level of care

Where it is running

• TMC HealthCare — Tucson, Arizona, United States
• Stanford University — Stanford, California, United States
• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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