Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19 (GO2 PEEP)
Clara Health

Bidirectional Oxygenation Valve in the Management of COVID-19

Sponsored by Emory University


The GO2 PEEP MOUTHPIECE is a simple, comfortable, and straightforward mouthpiece with a bidirectional valve that effectively delivers PEEP with every breath. Early application of the GO2 PEEP MOUTHPIECE in non-intubated COVID-19 patients may improve outcomes and save lives.

Furthermore, this device may allow for less strain on limited resources, especially ventilators. This PEEP mouthpiece could be employed under an oxygen non-rebreather mask to improve oxygenation and avoid intubation.

About 
COVID-19

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.

How is this study designed?

Study Type: Interventional (Clinical Trial) Estimated Enrollment: 5 participants Primary Purpose: Supportive Care Actual Study Start Date: April 8, 2020 Estimated Study Completion Date: May 2020

Who is this study for?

Inclusion Criteria*:

  • COVID-19 positive
  • Receiving oxygen by non-rebreather mask
  • Not currently requiring intubation

Exclusion Criteria*:

  • Cognitive impairment
  • Rapidly decompensating status requiring urgent or emergent higher level of care

* Additional criteria apply. Please speak with the study team for further information.

What should I expect?

The GO2 PEEP MOUTHPIECE has a bidirectional valve that delivers PEEP with each breath. Participants will be provided a G02 PEEP MOUTHPIECE to use underneath the oxygen face mask and will be instructed to breathe slowly and deeply through the mouthpiece for 15 minutes total.

Metrics for primary and secondary endpoints will be recorded immediately prior to use and then at 5, 10 and 15 minutes of use and then 15 minutes after cessation of use.

Inpatient trial

Have questions or need help?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.