N/A
N=2
Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04331366 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Oxygen Saturation by Pulse Oximetry — 92; 93.5; 94; 94 percentage of oxygen saturation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GO2 PEEP MOUTHPIECE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxygen Saturation by Pulse Oximetry |
92; 93.5; 94; 94; 92.5 | — |
| SECONDARY Respiratory Rate |
23.5; 20; 18; 17; 18.5 | — |
| SECONDARY Heart Rate |
84.5; 87.5; 90.5; 86.5; 86.5 | — |
| SECONDARY Blood Pressure |
152.5; 65; 155; 72.5; 150; 70 | — |
| SECONDARY Count of Participants With Subjective Work of Breathing |
1; 0; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04331366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.