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

Terminated

• Conditions: COVID
• Interventions: Device: CRI

• Registration Number: NCT04457817
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Study Start: 2020-12-01
• Primary Completion: 2021-04-08
• Study Completion: 2021-04-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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).

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Exclusion Criteria

• COVID-19 negative
• Age <18 or >70 years
• On <2 liters oxygen via nasal canula
• Pregnant
• Incarcerated
• DNR/DNI
• Decisionally Challenged

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRI Monitoring/Management	CRI	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.

Primary Outcome Measures

Name	Time	Method
FiO2 needs	1 year	FiO2 levels administered
Volume of IV fluid infused	1 year	Volume of IV fluid infused during treatment
Days on Oxygen	1 year	Days spent on oxygen
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
Number of Patients with Acute Kidney Injury (AKI)	1 year	Number of patients who acquire an acute kidney injury
mortality	1 year	Number of patients who experience mortality
Number of participants with hospital acquired pneumonia	1 year	Number of participants with hospital acquired pneumonia
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

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States