The objective of this study is to determine the safety, feasibility and efficacy of a bidirectional oxygenation Positive End Expiratory Pressure (PEEP) mouthpiece in coronavirus disease 2019 (COVID-19) patients requiring supplemental oxygen by non-rebreather mask.
Severe cases of COVID-19 often mimic the typical course of Adult Respiratory Distress
Syndrome (ARDS) and its predictable sequelae. These patients often require intubation and
ventilator support in order to sustain adequate oxygenation. Once a COVID-19 patient is
intubated, Positive End Expiratory Pressure (PEEP) is a mainstay of treatment and is used in
order to improve lung function, treat underlying atelectasis, improve oxygenation, and
improve survival. In fact, early clinical data as well as reports from front line physicians
treating COVID-19 suggest that PEEP has been the most effective treatment modality. In many
cases, PEEP has resulted in improved oxygenation and improved survival.
PEEP decreases the propensity for the alveoli to collapse by increasing the air pressure in
the lungs. This residual pressure in the lungs at the end of exhalation decreases shunting
and allows for more complete gas exchange and improved oxygenation. In patients, PEEP is one
of the safest ways to increase partial pressure of oxygen (PaO2) and is used on almost all
modern ventilator settings.
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.
Device: GO2 PEEP MOUTHPIECE
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.
Inclusion Criteria:
- COVID-19 positive
- Oxygen saturation <92%
- Able to provide informed consent
- Receiving oxygen by non-rebreather mask
- Not currently requiring intubation
Exclusion Criteria:
- Unable or unwilling to provide informed consent
- Cognitive impairment
- Rapidly decompensating status requiring urgent or emergent higher level of care
Emory University Hospital
Atlanta, Georgia, United States
Emory St. Joseph's Hospital
Atlanta, Georgia, United States
Jeffrey Miller, MD, Principal Investigator
Emory University