COVID
Conditions
Keywords
CRI, Compensatory Reserve Index, COVID-19, Coronavirus
Brief summary
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.
Interventions
DEVICECRI
Monitoring via CRI
Sponsors
Children's Hospital Colorado
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of IV fluid infused | 1 year | Volume of IV fluid infused during treatment |
| Quantity of Blood pressure medication administered | 1 year | Amount of blood pressure medication utilized during treatment |
| Resuscitation status | 1 year | Categorical determination of resuscitation status as over- or under- resuscitated |
| FiO2 needs | 1 year | FiO2 levels administered |
| Days on Oxygen | 1 year | Days spent on oxygen |
| Number of participants with hospital acquired pneumonia | 1 year | Number of participants with hospital acquired pneumonia |
| Number of Patients with Acute Kidney Injury (AKI) | 1 year | Number of patients who acquire an acute kidney injury |
| Number of patients with hemodynamic collapse | 1 year | Number of patients who experience hemodynamic collapse defined as drop in systolic blood pressure below 80mm Hg |
| mortality | 1 year | Number of patients who experience mortality |
Countries
United States
Outcome results
None listed