The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label. The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and additional research has been done since the FDA determination to further support the use of the device outside of its current labeling.
Device: CRI
Monitoring via CRI
Inclusion Criteria:
Eligible patients will be those who are:
- COVID-19 positive;
- Ages > 18 and < 70 years old;
- Require > 2 liters of oxygen by nasal cannula to maintain SpO2 > 90%;
- Are admitted to the sixth floor at University Hospital, on one of two designated
Hospitalist services (approximately 16 COVID-19 positive patients/service).
Exclusion Criteria:
- COVID-19 negative
- Age <18 or >70 years
- On <2 liters oxygen via nasal canula
- Pregnant
- Incarcerated
- DNR/DNI
- Decisionally Challenged
University of Colorado
Aurora, Colorado, United States
Steven L Moulton, MD, Principal Investigator
Children's Hospital Colorado