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

University of Colorado Denver (CU Denver)

Status: Terminated

Conditions: COVID

Treatments: Device: CRI

Study type: Observational

Funder types: Other

Identifiers

NCT04457817

20-1406

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

16 participants in 1 patient group

CRI Monitoring/Management

Description:

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.

Treatment:

Device: CRI