<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04457817</url>
  </required_header>
  <id_info>
    <org_study_id>20-1406</org_study_id>
    <nct_id>NCT04457817</nct_id>
  </id_info>
  <brief_title>Compensatory Reserve Index (CRI) for Management of COVID-19</brief_title>
  <official_title>CRI and Continuous Assessment of Hemodynamic Compensation to Guide Fluid and Pressor Management in Severely Ill Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital Colorado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this&#xD;
      study aims to evaluate the device in subjects aged outside of this range and is being used&#xD;
      off label.&#xD;
&#xD;
      The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and&#xD;
      additional research has been done since the FDA determination to further support the use of&#xD;
      the device outside of its current labeling.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of feasibility&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Actual">April 8, 2021</completion_date>
  <primary_completion_date type="Actual">April 8, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Volume of IV fluid infused</measure>
    <time_frame>1 year</time_frame>
    <description>Volume of IV fluid infused during treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantity of Blood pressure medication administered</measure>
    <time_frame>1 year</time_frame>
    <description>Amount of blood pressure medication utilized during treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resuscitation status</measure>
    <time_frame>1 year</time_frame>
    <description>Categorical determination of resuscitation status as over- or under- resuscitated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FiO2 needs</measure>
    <time_frame>1 year</time_frame>
    <description>FiO2 levels administered</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Days on Oxygen</measure>
    <time_frame>1 year</time_frame>
    <description>Days spent on oxygen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with hospital acquired pneumonia</measure>
    <time_frame>1 year</time_frame>
    <description>Number of participants with hospital acquired pneumonia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients with Acute Kidney Injury (AKI)</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients who acquire an acute kidney injury</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with hemodynamic collapse</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients who experience hemodynamic collapse defined as drop in systolic blood pressure below 80mm Hg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients who experience mortality</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>CRI Monitoring/Management</arm_group_label>
    <description>These patients are COVID-19 positive; ages &gt; 18 and &lt; 70 years old; require &gt; 2 liters of oxygen by nasal cannula to maintain SpO2 &gt; 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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CRI</intervention_name>
    <description>Monitoring via CRI</description>
    <arm_group_label>CRI Monitoring/Management</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        COVID-19 positive patients, Eligibility described above.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligible patients will be those who are:&#xD;
&#xD;
          -  COVID-19 positive;&#xD;
&#xD;
          -  Ages &gt; 18 and &lt; 70 years old;&#xD;
&#xD;
          -  Require &gt; 2 liters of oxygen by nasal cannula to maintain SpO2 &gt; 90%;&#xD;
&#xD;
          -  Are admitted to the sixth floor at University Hospital, on one of two designated&#xD;
             Hospitalist services (approximately 16 COVID-19 positive patients/service).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  COVID-19 negative&#xD;
&#xD;
          -  Age &lt;18 or &gt;70 years&#xD;
&#xD;
          -  On &lt;2 liters oxygen via nasal canula&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Incarcerated&#xD;
&#xD;
          -  DNR/DNI&#xD;
&#xD;
          -  Decisionally Challenged&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven L Moulton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Colorado</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19). Crit Care Med. 2020 Jun;48(6):e440-e469. doi: 10.1097/CCM.0000000000004363.</citation>
    <PMID>32224769</PMID>
  </reference>
  <reference>
    <citation>Convertino VA, Moulton SL, Grudic GZ, Rickards CA, Hinojosa-Laborde C, Gerhardt RT, Blackbourne LH, Ryan KL. Use of advanced machine-learning techniques for noninvasive monitoring of hemorrhage. J Trauma. 2011 Jul;71(1 Suppl):S25-32. doi: 10.1097/TA.0b013e3182211601.</citation>
    <PMID>21795890</PMID>
  </reference>
  <reference>
    <citation>Moulton SL, Mulligan J, Grudic GZ, Convertino VA. Running on empty? The compensatory reserve index. J Trauma Acute Care Surg. 2013 Dec;75(6):1053-9. doi: 10.1097/TA.0b013e3182aa811a.</citation>
    <PMID>24256681</PMID>
  </reference>
  <reference>
    <citation>Convertino VA, Schiller AM. Measuring the compensatory reserve to identify shock. J Trauma Acute Care Surg. 2017 Jun;82(6S Suppl 1):S57-S65. doi: 10.1097/TA.0000000000001430. No abstract available.</citation>
    <PMID>28333834</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26529655</PMID>
  </reference>
  <reference>
    <citation>Poh PY, Carter R 3rd, Hinojosa-Laborde C, Mulligan J, Grudic GZ, Convertino VA. Respiratory pump contributes to increased physiological reserve for compensation during simulated haemorrhage. Exp Physiol. 2014 Oct;99(10):1421-6. doi: 10.1113/expphysiol.2014.081208. Epub 2014 Jul 11.</citation>
    <PMID>25016024</PMID>
  </reference>
  <reference>
    <citation>Van Sickle C, Schafer K, Mulligan J, Grudic GZ, Moulton SL, Convertino VA. A sensitive shock index for real-time patient assessment during simulated hemorrhage. Aviat Space Environ Med. 2013 Sep;84(9):907-12. doi: 10.3357/asem.3606.2013.</citation>
    <PMID>24024301</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26884477</PMID>
  </reference>
  <reference>
    <citation>Hinojosa-Laborde C, Howard JT, Mulligan J, Grudic GZ, Convertino VA. Comparison of compensatory reserve during lower-body negative pressure and hemorrhage in nonhuman primates. Am J Physiol Regul Integr Comp Physiol. 2016 Jun 1;310(11):R1154-9. doi: 10.1152/ajpregu.00304.2015. Epub 2016 Mar 30.</citation>
    <PMID>27030667</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25423536</PMID>
  </reference>
  <reference>
    <citation>Nadler R, Convertino VA, Gendler S, Lending G, Lipsky AM, Cardin S, Lowenthal A, Glassberg E. The value of noninvasive measurement of the compensatory reserve index in monitoring and triage of patients experiencing minimal blood loss. Shock. 2014 Aug;42(2):93-8. doi: 10.1097/SHK.0000000000000178.</citation>
    <PMID>24667628</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25565640</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27172155</PMID>
  </reference>
  <reference>
    <citation>Johnson MC, Alarhayem A, Convertino V, Carter R 3rd, Chung K, Stewart R, Myers J, Dent D, Liao L, Cestero R, Nicholson S, Muir M, Schwacha M, Wampler D, DeRosa M, Eastridge B. Compensatory Reserve Index: Performance of A Novel Monitoring Technology to Identify the Bleeding Trauma Patient. Shock. 2018 Mar;49(3):295-300. doi: 10.1097/SHK.0000000000000959.</citation>
    <PMID>28767544</PMID>
  </reference>
  <reference>
    <citation>Johnson MC, Alarhayem A, Convertino V, Carter R 3rd, Chung K, Stewart R, Myers J, Dent D, Liao L, Cestero R, Nicholson S, Muir M, Schwaca M, Wampler D, DeRosa M, Eastridge BJ. Comparison of compensatory reserve and arterial lactate as markers of shock and resuscitation. J Trauma Acute Care Surg. 2017 Oct;83(4):603-608. doi: 10.1097/TA.0000000000001595.</citation>
    <PMID>28930955</PMID>
  </reference>
  <reference>
    <citation>Choi YM, Leopold D, Campbell K, Mulligan J, Grudic GZ, Moulton SL. Noninvasive monitoring of physiologic compromise in acute appendicitis: New insight into an old disease. J Pediatr Surg. 2018 Feb;53(2):241-246. doi: 10.1016/j.jpedsurg.2017.11.013. Epub 2017 Nov 13.</citation>
    <PMID>29217323</PMID>
  </reference>
  <reference>
    <citation>Benov A, Brand A, Rozenblat T, Antebi B, Ben-Ari A, Amir-Keret R, Nadler R, Chen J, Chung KK, Convertino VA, Paran H. Evaluation of sepsis using compensatory reserve measurement: A prospective clinical trial. J Trauma Acute Care Surg. 2020 Aug;89(2S Suppl 2):S153-S160. doi: 10.1097/TA.0000000000002648.</citation>
    <PMID>32118823</PMID>
  </reference>
  <reference>
    <citation>Gagnon D, Schlader ZJ, Adams A, Rivas E, Mulligan J, Grudic GZ, Convertino VA, Howard JT, Crandall CG. The Effect of Passive Heat Stress and Exercise-Induced Dehydration on the Compensatory Reserve During Simulated Hemorrhage. Shock. 2016 Sep;46(3 Suppl 1):74-82. doi: 10.1097/SHK.0000000000000653.</citation>
    <PMID>27183303</PMID>
  </reference>
  <reference>
    <citation>Ehrmann DE, Leopold DK, Phillips R, Shahi N, Campbell K, Ross M, Zablah JE, Moulton SL, Morgan G, Kim JS. The Compensatory Reserve Index Responds to Acute Hemodynamic Changes in Patients with Congenital Heart Disease: A Proof of Concept Study. Pediatr Cardiol. 2020 Aug;41(6):1190-1198. doi: 10.1007/s00246-020-02374-3. Epub 2020 May 30.</citation>
    <PMID>32474738</PMID>
  </reference>
  <reference>
    <citation>Stewart CL, Mulligan J, Grudic GZ, Pyle L, Moulton SL. A noninvasive computational method for fluid resuscitation monitoring in pediatric burns: a preliminary report. J Burn Care Res. 2015 Jan-Feb;36(1):145-50. doi: 10.1097/BCR.0000000000000178.</citation>
    <PMID>25383980</PMID>
  </reference>
  <reference>
    <citation>Stewart CL, Nawn CD, Mulligan J, Grudic G, Moulton SL, Convertino VA. Compensatory Reserve for Early and Accurate Prediction of Hemodynamic Compromise: Case Studies for Clinical Utility in Acute Care and Physical Performance. J Spec Oper Med. 2016 Spring;16(1):6-13.</citation>
    <PMID>27045488</PMID>
  </reference>
  <reference>
    <citation>Leopold DK, Phillips RC, Shahi N, Gien J, Marwan AI, Kinsella JP, Mulligan J, Liechty KW, Moulton SL. Low postnatal CRI values are associated with the need for ECMO in newborns with CDH. J Pediatr Surg. 2020 Jan;55(1):39-44. doi: 10.1016/j.jpedsurg.2019.09.050. Epub 2019 Oct 25.</citation>
    <PMID>31679772</PMID>
  </reference>
  <reference>
    <citation>Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14. Erratum In: Clin Infect Dis. 2017 May 1;64(9):1298. Clin Infect Dis. 2017 Oct 15;65(8):1435. Clin Infect Dis. 2017 Nov 29;65(12):2161.</citation>
    <PMID>27418577</PMID>
  </reference>
  <reference>
    <citation>Alexander PMA, DiOrio M, Andren K, Gauvreau K, Mistry KP, Mathieu D, Wright J, Allan CK, Nathan M, Mayer JE Jr, Thiagarajan RR, Bergersen L. Accurate Prediction of Congenital Heart Surgical Length of Stay Incorporating a Procedure-Based Categorical Variable. Pediatr Crit Care Med. 2018 Oct;19(10):949-956. doi: 10.1097/PCC.0000000000001668.</citation>
    <PMID>30052551</PMID>
  </reference>
  <reference>
    <citation>Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. doi: 10.1001/jama.286.14.1754.</citation>
    <PMID>11594901</PMID>
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    <citation>ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.</citation>
    <PMID>22797452</PMID>
  </reference>
  <reference>
    <citation>Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.</citation>
    <PMID>22890468</PMID>
  </reference>
  <reference>
    <citation>Convertino VA, Wampler MR, Johnson M, Alarhayem A, Le TD, Nicholson S, Myers JG, Chung KK, Struck KR, Cuenca C, Eastridge BJ. Validating clinical threshold values for a dashboard view of the compensatory reserve measurement for hemorrhage detection. J Trauma Acute Care Surg. 2020 Aug;89(2S Suppl 2):S169-S174. doi: 10.1097/TA.0000000000002586.</citation>
    <PMID>31972755</PMID>
  </reference>
  <reference>
    <citation>Silversides JA, Major E, Ferguson AJ, Mann EE, McAuley DF, Marshall JC, Blackwood B, Fan E. Conservative fluid management or deresuscitation for patients with sepsis or acute respiratory distress syndrome following the resuscitation phase of critical illness: a systematic review and meta-analysis. Intensive Care Med. 2017 Feb;43(2):155-170. doi: 10.1007/s00134-016-4573-3. Epub 2016 Oct 12.</citation>
    <PMID>27734109</PMID>
  </reference>
  <reference>
    <citation>National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.</citation>
    <PMID>16714767</PMID>
  </reference>
  <reference>
    <citation>Erickson SE, Martin GS, Davis JL, Matthay MA, Eisner MD; NIH NHLBI ARDS Network. Recent trends in acute lung injury mortality: 1996-2005. Crit Care Med. 2009 May;37(5):1574-9. doi: 10.1097/CCM.0b013e31819fefdf.</citation>
    <PMID>19325464</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CRI</keyword>
  <keyword>Compensatory Reserve Index</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Coronavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available to other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04457817
org study id: 20-1406
nct id: NCT04457817
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
observational model: Cohort
time perspective: Prospective
measure: Volume of IV fluid infused
time frame: 1 year
description: Volume of IV fluid infused during treatment
measure: Quantity of Blood pressure medication administered
time frame: 1 year
description: Amount of blood pressure medication utilized during treatment
measure: Resuscitation status
time frame: 1 year
description: Categorical determination of resuscitation status as over- or under- resuscitated
measure: FiO2 needs
time frame: 1 year
description: FiO2 levels administered
measure: Days on Oxygen
time frame: 1 year
description: Days spent on oxygen
measure: Number of participants with hospital acquired pneumonia
time frame: 1 year
description: Number of participants with hospital acquired pneumonia
measure: Number of Patients with Acute Kidney Injury (AKI)
time frame: 1 year
description: Number of patients who acquire an acute kidney injury
measure: Number of patients with hemodynamic collapse
time frame: 1 year
description: Number of patients who experience hemodynamic collapse defined as drop in systolic blood pressure below 80mm Hg
measure: mortality
time frame: 1 year
description: Number of patients who experience mortality
arm group label: 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.
intervention type: Device
intervention name: CRI
description: Monitoring via CRI
arm group label: CRI Monitoring/Management
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Steven L Moulton, MD
role: Principal Investigator
affiliation: Children's Hospital Colorado
facility: 
country: United States
citation: Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19). Crit Care Med. 2020 Jun;48(6):e440-e469. doi: 10.1097/CCM.0000000000004363.
PMID: 32224769
citation: Convertino VA, Moulton SL, Grudic GZ, Rickards CA, Hinojosa-Laborde C, Gerhardt RT, Blackbourne LH, Ryan KL. Use of advanced machine-learning techniques for noninvasive monitoring of hemorrhage. J Trauma. 2011 Jul;71(1 Suppl):S25-32. doi: 10.1097/TA.0b013e3182211601.
PMID: 21795890
citation: Moulton SL, Mulligan J, Grudic GZ, Convertino VA. Running on empty? The compensatory reserve index. J Trauma Acute Care Surg. 2013 Dec;75(6):1053-9. doi: 10.1097/TA.0b013e3182aa811a.
PMID: 24256681
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citation: 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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responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
ipd description: There is no plan to make individual participant data available to other researchers