Compensatory Reserve Index (CRI) for Management of COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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CRI and Continuous Assessment of Hemodynamic Compensation to Guide Fluid and Pressor Management in Severely Ill Patients With COVID-19

Conditions
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COVID

Intervention / Treatment
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* Device: CRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRI Monitoring/Management<br>These patients 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). Patients in the study cohort will also be monitored with a CipherOx CR T1 tablet in a continuous manner to determine if maintaining CRI vales between 0.9-0.7 will: 1) help guide IV fluid (e.g. crystalloid, colloids, blood products) and medication therapy (e.g. diuretics); 2) allows earlier identification of patients who are poorly compensating and will require ICU level care; 3) reduces AKI and/or need for CRRT; and 4) improves clinical outcomes. | Device: CRI<br>* Monitoring via CRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of IV fluid infused | Volume of IV fluid infused during treatment | 1 year | 
| Quantity of Blood pressure medication administered | Amount of blood pressure medication utilized during treatment | 1 year | 
| Resuscitation status | Categorical determination of resuscitation status as over- or under- resuscitated | 1 year | 
| FiO2 needs | FiO2 levels administered | 1 year | 
| Days on Oxygen | Days spent on oxygen | 1 year | 
| Number of participants with hospital acquired pneumonia | Number of participants with hospital acquired pneumonia | 1 year | 
| Number of Patients with Acute Kidney Injury (AKI) | Number of patients who acquire an acute kidney injury | 1 year | 
| Number of patients with hemodynamic collapse | Number of patients who experience hemodynamic collapse defined as drop in systolic blood pressure below 80mm Hg | 1 year | 
| mortality | Number of patients who experience mortality | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRI, Compensatory Reserve Index, COVID-19, Coronavirus