<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/NCT03264833</url>
  </required_header>
  <id_info>
    <org_study_id>16-115</org_study_id>
    <nct_id>NCT03264833</nct_id>
  </id_info>
  <brief_title>Accuracy and Precision Comparison of Temptraq</brief_title>
  <official_title>Accuracy and Precision Test of TempTraq® Compared to Pulmonary Artery Catheter for Monitoring Temperature in Adults in Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Blue Spark Technologies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose The purpose of this feasibility study is to assess the accuracy and precision of the&#xD;
      Temp-Traq thermometer for monitoring body temperature in adult patients under three&#xD;
      conditions (hypothermia, normothermia, and hyperthermia).&#xD;
&#xD;
      Specific Aims&#xD;
&#xD;
        1. To assess the accuracy of the Temp-Traq thermometer as compared to a gold standard (Core&#xD;
           temp measured by Pulmonary Artery Catheter)&#xD;
&#xD;
        2. To assess the precision of the Temp-Traq thermometer over repeated measures&#xD;
&#xD;
        3. To determine if accuracy &amp;/or precision is consistent in three conditions (hypothermia,&#xD;
           normothermia, or hyperthermia)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design A repeated measures within-group comparative design will be used for this study.&#xD;
&#xD;
      Sample/Setting To address the specific aims of this study the investigators will identify&#xD;
      patients (N = 40) who have a pulmonary artery (PA) catheter in place (patients in intensive&#xD;
      care units). Letters of support are attached from the unit managers where the study will take&#xD;
      place (see attached).&#xD;
&#xD;
      Procedure Once a patient is identified, the researcher will record basic demographic data&#xD;
      (see data collection form attached) and the axillary area will be assessed for visible signs&#xD;
      of any skin conditions. If there are no visible signs of a skin condition the researcher will&#xD;
      apply the Temp-Traq thermometer to the right or left axilla of the subject and record the&#xD;
      location of the placement. The researcher will record both the PA and Temp-Traq recordings of&#xD;
      subject's temperature (taken at the same time) on the data collection form (see attachment)&#xD;
      at four data points; baseline (5 minutes post application of Temp-Traq) and every two hours&#xD;
      (+/- 15 minutes) after baseline X 3. Previous testing of the TempTraq® on children and&#xD;
      healthy adults has not resulted in any adverse skin reactions. However, as this is a new&#xD;
      thermometer format and there is not a significant body of literature on potential skin&#xD;
      reactions, the investigators will assess skin before and after application. Thus, at the end&#xD;
      of the last reading the Temp-Traq thermometer will be removed and the skin will be assessed&#xD;
      for erythema. If erythema is present the patient's nurse and physician will be notified by&#xD;
      the researcher.&#xD;
&#xD;
      Protection of Human Subjects Since non-invasive temperature monitoring poses no risk to&#xD;
      patients and is part of usual care and since the investigators will not collect or record any&#xD;
      protected health information (PHI), written informed consent will not be sought. Patients&#xD;
      will be identified by their study ID number only. The data will be collected by a registered&#xD;
      nurse data collector familiar with the intensive care setting and data will be stored in a&#xD;
      locked file cabinet in the researchers locked office. Temperature data for the Temp-Traq is&#xD;
      collected through the Temp-Traq Application (AP) which will be placed on a Cleveland Clinic&#xD;
      Approved and encrypted i-pad. Once the study is completed and all data has been transferred&#xD;
      to the study database, the Temp-Traq application and all of its data will be deleted from the&#xD;
      i-pad.&#xD;
&#xD;
      Analysis The investigators will use the TOST (Two One Sided t-tests) method for equivalence&#xD;
      testing. This method requires a defined range of mean differences between two test methods,&#xD;
      an estimate of the precision of the measurement of the two systems, and an estimate of the&#xD;
      size of the possible difference in the means of the two methods under consideration. The TOST&#xD;
      null hypothesis is a joint null hypothesis that the mean measurement differences between the&#xD;
      two methods is greater than a critical lower bound and less than a critical upper bound. If&#xD;
      the null is rejected then the investigators can conclude that the absolute difference of the&#xD;
      means for the two groups falls within the specified range. It was determined that to be&#xD;
      considered equivalent with respect to accuracy the mean measurements of the two methods&#xD;
      should be within ± 0.2 degrees of each other. Precision tests for Temp-Traq thermometer using&#xD;
      accepted ASTM test methods for various combinations of temperature and humidity provided a&#xD;
      range of measurement variation between .0000435 and .019928 with a mean of 0.000254500. If&#xD;
      the investigators assume both test methods exhibit the same levels of precision then the&#xD;
      variance of the differences between their two means will reduce to two times the values&#xD;
      listed previously. This will result in estimates of the standard deviations of the mean&#xD;
      differences of .0093, .032, and .063 respectively.&#xD;
&#xD;
      The two methods for body temperature that will be examined are core temperature measurements&#xD;
      with a PA catheter and temperature measurements using the Temp-Traq (measured in Celsius).&#xD;
      Paired temperature measurements for both methods will be taken simultaneously every 2 hours&#xD;
      for a 6 hour period. This will provide 4 repeated temperature measures per patient. The&#xD;
      simultaneous measurements within a given patient should exhibit a high degree of correlation.&#xD;
      If .7 is chosen as the lower bound for the correlation between the paired readings (higher&#xD;
      correlations would result in an estimate of fewer patient samples thus the choice of .7 is&#xD;
      conservative) and if the average standard deviation of the mean of the differences is used as&#xD;
      an estimate of the expected variability, then it would be possible to declare measurement&#xD;
      equivalence for a difference of ±.19 with a sample size of 40 patients. This assumes the ASTM&#xD;
      measurements of instrument variation are representative of the within patient variance. Given&#xD;
      the vagaries of patient-to-patient this may be too optimistic an estimate.&#xD;
&#xD;
      A sample size of 40 patients will provide 80% or greater power for testing for equivalence&#xD;
      between methods where the mean difference is .1 or less for up to a ten-fold increase in the&#xD;
      estimates of the variability of the differences based on the ASTM precision measures and for&#xD;
      a mean difference of .15 for up to a five-fold increase in these same measures. If the sample&#xD;
      size is 40 then the power for the test of equivalence, where the difference is .15 and the&#xD;
      standard deviation is a ten-fold increase, is 35%. Agreement testing: The Bland-Altman test&#xD;
      will be used to test the agreement of the two methods. This test will permit a check for&#xD;
      significance of bias between the two measures (the average difference between the two&#xD;
      measures) as well as a check for significant trending over the range of the measurements. If&#xD;
      the bias is significant then the results of the two differ by an overall offset in their&#xD;
      measurements. If the trending (slope of the regression line) is significant then the&#xD;
      difference between the two measurements changes as their magnitude changes which means the&#xD;
      two methods are not in agreement.&#xD;
&#xD;
      The only measurements of instrument precision are those provided by the ASTM assessment. It&#xD;
      is reasonable to assume the within patient measurement variation will be greater than the&#xD;
      measurements from the controlled testing. A sample size of 40 patients is, from a statistical&#xD;
      standpoint, a reasonable number and this sample size provides acceptable power for a mean&#xD;
      difference of .1 for a ten-fold increase in the estimate of minimum test variability. This&#xD;
      sample size will also provide enough data for the Bland-Altman test for agreement. Because&#xD;
      this is a repeated measures test and even one missing measurement will impact the results,&#xD;
      the investigators plan to over-sample in order to assure the study has the power to answer&#xD;
      the questions posed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 15, 2016</start_date>
  <completion_date type="Anticipated">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">February 1, 2017</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>Accuracy and precision of TempTraq thermometer- Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy and precision of TempTraq thermometer-Time 2</measure>
    <time_frame>2 hours post baseline</time_frame>
    <description>Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy and precision of TempTraq thermometer-Time 3</measure>
    <time_frame>4 hours post baseline</time_frame>
    <description>Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy and precision of TempTraq thermometer-Time 4</measure>
    <time_frame>6 hours post baseline</time_frame>
    <description>Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Temperature</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TempTraq</intervention_name>
    <description>no intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        To address the specific aims of this study the investigators will identify patients (N =&#xD;
        40) who have a pulmonary artery (PA) catheter in place (patients in intensive care units).&#xD;
        Letters of support are attached from the unit managers where the study will take place.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria Adult patient (male or female) in intensive care unit who will have a PA&#xD;
        catheter in place for at least the next 8 hours; and who have no visible skin condition to&#xD;
        the axillary region upon inspection by the research nurse are eligible for this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients younger than 21&#xD;
&#xD;
          2. Patients who will not have a PA catheter in place for the next 8 hours&#xD;
&#xD;
          3. Patients who have a visible skin condition to the axillary region upon inspection by&#xD;
             the research nurse&#xD;
&#xD;
          4. Patients who will be going for procedures or for some reason will not be available for&#xD;
             the 6 hours of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <reference>
    <citation>Eliades, A, Stoner, K. and Frisone, J. (unpublished paper) Use of skin patch device to obtain temperature measurements</citation>
  </reference>
  <reference>
    <citation>Farnell S, Maxwell L, Tan S, Rhodes A, Philips B. Temperature measurement: comparison of non-invasive methods used in adult critical care. J Clin Nurs. 2005 May;14(5):632-9. doi: 10.1111/j.1365-2702.2004.00916.x.</citation>
    <PMID>15840078</PMID>
  </reference>
  <reference>
    <citation>Lawson L, Bridges EJ, Ballou I, Eraker R, Greco S, Shively J, Sochulak V. Accuracy and precision of noninvasive temperature measurement in adult intensive care patients. Am J Crit Care. 2007 Sep;16(5):485-96.</citation>
    <PMID>17724246</PMID>
  </reference>
  <reference>
    <citation>Pinsky MR, Vincent JL. Let us use the pulmonary artery catheter correctly and only when we need it. Crit Care Med. 2005 May;33(5):1119-22. doi: 10.1097/01.ccm.0000163238.64905.56.</citation>
    <PMID>15891346</PMID>
  </reference>
  <reference>
    <citation>Sund-Levander M, Grodzinsky E. Assessment of body temperature measurement options. Br J Nurs. 2013 Aug 8-Sep 12;22(15):880, 882-8. No abstract available.</citation>
    <PMID>24052967</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Sandra Siedlecki</investigator_full_name>
    <investigator_title>Senior Nurse Scientist</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>July 7, 2020</submitted>
    <returned>July 23, 2020</returned>
  </pending_results>
  <!-- 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/NCT03264833
org study id: 16-115
nct id: NCT03264833
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose The purpose of this feasibility study is to assess the accuracy and precision of the
      Temp-Traq thermometer for monitoring body temperature in adult patients under three
      conditions (hypothermia, normothermia, and hyperthermia).

      Specific Aims

        1. To assess the accuracy of the Temp-Traq thermometer as compared to a gold standard (Core
           temp measured by Pulmonary Artery Catheter)

        2. To assess the precision of the Temp-Traq thermometer over repeated measures

        3. To determine if accuracy &/or precision is consistent in three conditions (hypothermia,
           normothermia, or hyperthermia)
Design A repeated measures within-group comparative design will be used for this study.

      Sample/Setting To address the specific aims of this study the investigators will identify
      patients (N = 40) who have a pulmonary artery (PA) catheter in place (patients in intensive
      care units). Letters of support are attached from the unit managers where the study will take
      place (see attached).

      Procedure Once a patient is identified, the researcher will record basic demographic data
      (see data collection form attached) and the axillary area will be assessed for visible signs
      of any skin conditions. If there are no visible signs of a skin condition the researcher will
      apply the Temp-Traq thermometer to the right or left axilla of the subject and record the
      location of the placement. The researcher will record both the PA and Temp-Traq recordings of
      subject's temperature (taken at the same time) on the data collection form (see attachment)
      at four data points; baseline (5 minutes post application of Temp-Traq) and every two hours
      (+/- 15 minutes) after baseline X 3. Previous testing of the TempTraq® on children and
      healthy adults has not resulted in any adverse skin reactions. However, as this is a new
      thermometer format and there is not a significant body of literature on potential skin
      reactions, the investigators will assess skin before and after application. Thus, at the end
      of the last reading the Temp-Traq thermometer will be removed and the skin will be assessed
      for erythema. If erythema is present the patient's nurse and physician will be notified by
      the researcher.

      Protection of Human Subjects Since non-invasive temperature monitoring poses no risk to
      patients and is part of usual care and since the investigators will not collect or record any
      protected health information (PHI), written informed consent will not be sought. Patients
      will be identified by their study ID number only. The data will be collected by a registered
      nurse data collector familiar with the intensive care setting and data will be stored in a
      locked file cabinet in the researchers locked office. Temperature data for the Temp-Traq is
      collected through the Temp-Traq Application (AP) which will be placed on a Cleveland Clinic
      Approved and encrypted i-pad. Once the study is completed and all data has been transferred
      to the study database, the Temp-Traq application and all of its data will be deleted from the
      i-pad.

      Analysis The investigators will use the TOST (Two One Sided t-tests) method for equivalence
      testing. This method requires a defined range of mean differences between two test methods,
      an estimate of the precision of the measurement of the two systems, and an estimate of the
      size of the possible difference in the means of the two methods under consideration. The TOST
      null hypothesis is a joint null hypothesis that the mean measurement differences between the
      two methods is greater than a critical lower bound and less than a critical upper bound. If
      the null is rejected then the investigators can conclude that the absolute difference of the
      means for the two groups falls within the specified range. It was determined that to be
      considered equivalent with respect to accuracy the mean measurements of the two methods
      should be within ± 0.2 degrees of each other. Precision tests for Temp-Traq thermometer using
      accepted ASTM test methods for various combinations of temperature and humidity provided a
      range of measurement variation between .0000435 and .019928 with a mean of 0.000254500. If
      the investigators assume both test methods exhibit the same levels of precision then the
      variance of the differences between their two means will reduce to two times the values
      listed previously. This will result in estimates of the standard deviations of the mean
      differences of .0093, .032, and .063 respectively.

      The two methods for body temperature that will be examined are core temperature measurements
      with a PA catheter and temperature measurements using the Temp-Traq (measured in Celsius).
      Paired temperature measurements for both methods will be taken simultaneously every 2 hours
      for a 6 hour period. This will provide 4 repeated temperature measures per patient. The
      simultaneous measurements within a given patient should exhibit a high degree of correlation.
      If .7 is chosen as the lower bound for the correlation between the paired readings (higher
      correlations would result in an estimate of fewer patient samples thus the choice of .7 is
      conservative) and if the average standard deviation of the mean of the differences is used as
      an estimate of the expected variability, then it would be possible to declare measurement
      equivalence for a difference of ±.19 with a sample size of 40 patients. This assumes the ASTM
      measurements of instrument variation are representative of the within patient variance. Given
      the vagaries of patient-to-patient this may be too optimistic an estimate.

      A sample size of 40 patients will provide 80% or greater power for testing for equivalence
      between methods where the mean difference is .1 or less for up to a ten-fold increase in the
      estimates of the variability of the differences based on the ASTM precision measures and for
      a mean difference of .15 for up to a five-fold increase in these same measures. If the sample
      size is 40 then the power for the test of equivalence, where the difference is .15 and the
      standard deviation is a ten-fold increase, is 35%. Agreement testing: The Bland-Altman test
      will be used to test the agreement of the two methods. This test will permit a check for
      significance of bias between the two measures (the average difference between the two
      measures) as well as a check for significant trending over the range of the measurements. If
      the bias is significant then the results of the two differ by an overall offset in their
      measurements. If the trending (slope of the regression line) is significant then the
      difference between the two measurements changes as their magnitude changes which means the
      two methods are not in agreement.

      The only measurements of instrument precision are those provided by the ASTM assessment. It
      is reasonable to assume the within patient measurement variation will be greater than the
      measurements from the controlled testing. A sample size of 40 patients is, from a statistical
      standpoint, a reasonable number and this sample size provides acceptable power for a mean
      difference of .1 for a ten-fold increase in the estimate of minimum test variability. This
      sample size will also provide enough data for the Bland-Altman test for agreement. Because
      this is a repeated measures test and even one missing measurement will impact the results,
      the investigators plan to over-sample in order to assure the study has the power to answer
      the questions posed.
observational model: Cohort
time perspective: Prospective
measure: Accuracy and precision of TempTraq thermometer- Baseline
time frame: Baseline
description: Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister
measure: Accuracy and precision of TempTraq thermometer-Time 2
time frame: 2 hours post baseline
description: Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister
measure: Accuracy and precision of TempTraq thermometer-Time 3
time frame: 4 hours post baseline
description: Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister
measure: Accuracy and precision of TempTraq thermometer-Time 4
time frame: 6 hours post baseline
description: Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister
intervention type: Other
intervention name: TempTraq
description: no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
citation: Eliades, A, Stoner, K. and Frisone, J. (unpublished paper) Use of skin patch device to obtain temperature measurements
citation: Farnell S, Maxwell L, Tan S, Rhodes A, Philips B. Temperature measurement: comparison of non-invasive methods used in adult critical care. J Clin Nurs. 2005 May;14(5):632-9. doi: 10.1111/j.1365-2702.2004.00916.x.
PMID: 15840078
citation: Lawson L, Bridges EJ, Ballou I, Eraker R, Greco S, Shively J, Sochulak V. Accuracy and precision of noninvasive temperature measurement in adult intensive care patients. Am J Crit Care. 2007 Sep;16(5):485-96.
PMID: 17724246
citation: Pinsky MR, Vincent JL. Let us use the pulmonary artery catheter correctly and only when we need it. Crit Care Med. 2005 May;33(5):1119-22. doi: 10.1097/01.ccm.0000163238.64905.56.
PMID: 15891346
citation: Sund-Levander M, Grodzinsky E. Assessment of body temperature measurement options. Br J Nurs. 2013 Aug 8-Sep 12;22(15):880, 882-8. No abstract available.
PMID: 24052967
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Sandra Siedlecki
investigator title: Senior Nurse Scientist
sharing ipd: No
ipd description: IPD will not be shared
submitted: July 7, 2020
returned: July 23, 2020