Compensatory Reserve Index (CRI) for Management of COVID-19
NCT ID: NCT04457817
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
16 participants
OBSERVATIONAL
2020-12-01
2021-04-08
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CRI Monitoring/Management
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.
CRI
Monitoring via CRI
Interventions
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CRI
Monitoring via CRI
Eligibility Criteria
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Inclusion Criteria
* 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
* Age \<18 or \>70 years
* On \<2 liters oxygen via nasal canula
* Pregnant
* Incarcerated
* DNR/DNI
* Decisionally Challenged
18 Years
70 Years
ALL
No
Sponsors
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Children's Hospital Colorado
OTHER
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Steven L Moulton, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado
Locations
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University of Colorado
Aurora, Colorado, United States
Countries
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References
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Janak JC, Howard JT, Goei KA, Weber R, Muniz GW, Hinojosa-Laborde C, Convertino VA. Predictors of the Onset of Hemodynamic Decompensation During Progressive Central Hypovolemia: Comparison of the Peripheral Perfusion Index, Pulse Pressure Variability, and Compensatory Reserve Index. Shock. 2015 Dec;44(6):548-53. doi: 10.1097/SHK.0000000000000480.
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Carter R 3rd, Hinojosa-Laborde C, Convertino VA. Variability in integration of mechanisms associated with high tolerance to progressive reductions in central blood volume: the compensatory reserve. Physiol Rep. 2016 Feb;4(4):e12705. doi: 10.14814/phy2.12705.
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Stewart CL, Mulligan J, Grudic GZ, Convertino VA, Moulton SL. Detection of low-volume blood loss: compensatory reserve versus traditional vital signs. J Trauma Acute Care Surg. 2014 Dec;77(6):892-7; discussion 897-8. doi: 10.1097/TA.0000000000000423.
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Convertino VA, Howard JT, Hinojosa-Laborde C, Cardin S, Batchelder P, Mulligan J, Grudic GZ, Moulton SL, MacLeod DB. Individual-Specific, Beat-to-beat Trending of Significant Human Blood Loss: The Compensatory Reserve. Shock. 2015 Aug;44 Suppl 1:27-32. doi: 10.1097/SHK.0000000000000323.
Stewart CL, Mulligan J, Grudic GZ, Talley ME, Jurkovich GJ, Moulton SL. The Compensatory Reserve Index Following Injury: Results of a Prospective Clinical Trial. Shock. 2016 Sep;46(3 Suppl 1):61-7. doi: 10.1097/SHK.0000000000000647.
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Other Identifiers
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20-1406
Identifier Type: -
Identifier Source: org_study_id