<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/NCT04506333</url>
  </required_header>
  <id_info>
    <org_study_id>1017</org_study_id>
    <nct_id>NCT04506333</nct_id>
  </id_info>
  <brief_title>Validation of A&amp;D UA-651 in Children</brief_title>
  <official_title>Validation of the A&amp;D UA-651 Oscillometric Blood Pressure Monitor in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisiana Monroe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Louisiana Monroe</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>
      This study will determine if the A&amp;D UA-651 blood pressure monitor is valid in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>The ISO/ESH/AAMI standards for validating blood pressure measurement devices will be used. In this model, participants' blood pressures are taken alternating between the test device and a reference device.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Investigators and assessors will need to know which device is associated with each measurement to perform analysis as specified in ISO/ESH/AAMI standards, but observers taking manual reference blood pressure measurements will be blinded as to each other's measurements.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure Triplet</measure>
    <time_frame>Immediate</time_frame>
    <description>A valid set of 3 measurements (reference-test-reference) will be considered one outcome measurement for validation.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>Small Cuff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with an upper-arm circumference of 6.3-9.4&quot; may be placed in the small cuff arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium Cuff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with an upper-arm circumference of 9.0-14.6&quot; may be placed in the medium cuff arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lage Cuff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with an upper-arm circumference of 12.2-17.7&quot; may be placed in the large cuff arm.&#xD;
The large cuff arm will use an adaptive study design. Per the AAMI/ESH/ISO standards, at least 1/6 of participants must fall into each cuff size arm for that cuff size, and of the participants assigned to each cuff size, at least 40% of those must fall in the upper and lower half of the cuff's size range. However, we do not anticipate many participants in our age range falling in the upper half of the large cuff size range (upper arm circumference &gt; 14.95&quot;).&#xD;
Because of this, our plan is to validate the large cuff, but if enrolling a patient with a large cuff would require additional patients be enrolled to reach 1/6 of the total sample, the large cuff will be dropped from consideration and the validation completed with only the small and medium cuffs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>A&amp;D UA-651 Blood Pressure Monitor</intervention_name>
    <description>Test device to be validated.</description>
    <arm_group_label>Lage Cuff</arm_group_label>
    <arm_group_label>Medium Cuff</arm_group_label>
    <arm_group_label>Small Cuff</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ADC 740-N Manual Sphygmomanometer</intervention_name>
    <description>Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.</description>
    <arm_group_label>Lage Cuff</arm_group_label>
    <arm_group_label>Medium Cuff</arm_group_label>
    <arm_group_label>Small Cuff</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent permission&#xD;
&#xD;
          -  Assent for participants aged 7-12&#xD;
&#xD;
          -  Additional sequential selection criteria (described below)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Withdrawal of permission or assent&#xD;
&#xD;
          -  Younger than 3 or older than 12 years of age&#xD;
&#xD;
          -  Uncooperative participants, defined as refusing instructions from study personnel,&#xD;
             coordinators, or observers&#xD;
&#xD;
          -  Physical preclusion to taking blood pressure&#xD;
&#xD;
          -  Participants who have any reference blood pressure measurement exceeding the 95th&#xD;
             percentile plus 30mmHg for their age, sex, and height (urgent blood pressure level as&#xD;
             defined by the American Academy of Pediatrics)&#xD;
&#xD;
          -  Participants with systolic blood pressure difference of greater than 12mmHg or&#xD;
             diastolic blood pressure difference of greater than 8mmHg between any two reference&#xD;
             measurements&#xD;
&#xD;
        Sequential Selection Criteria:&#xD;
&#xD;
        Participants will be selected sequentially during study events. Per ISO/ESH/AAMI standards,&#xD;
        participants must meet the following characteristics:&#xD;
&#xD;
          -  at least 30% male and 30% female&#xD;
&#xD;
          -  at least 1/6 using each of the three available cuff sizes (small, medium, large)&#xD;
&#xD;
          -  for each cuff size, at least 40% in the upper half of the arm circumference range and&#xD;
             at least 40% in the lower half of the arm circumference range.&#xD;
&#xD;
        If including a participant would require that additional participants be enrolled to meet&#xD;
        the above criteria, that participant will not be included. For example, if only 2 small&#xD;
        cuff participants are needed to complete the study, but a prospective participant would&#xD;
        require a large cuff AND including that participant will require additional small or medium&#xD;
        cuff participants to complete the study, then that prospective participant will not be&#xD;
        included.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bryan J Donald, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Louisiana Monroe</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bryan J Donald, PharmD</last_name>
    <phone>318-342-1903</phone>
    <email>donald@ulm.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jessica Brady, PharmD</last_name>
    <phone>318-342-1697</phone>
    <email>brady@ulm.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Louisiana Monroe College of Pharmacy</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71201</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Bryan J Donald, PharmD</last_name>
      <phone>318-342-1903</phone>
      <email>donald@ulm.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Stergiou GS, Palatini P, Asmar R, Ioannidis JP, Kollias A, Lacy P, McManus RJ, Myers MG, Parati G, Shennan A, Wang J, O'Brien E; European Society of Hypertension Working Group on Blood Pressure Monitoring. Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO). J Hypertens. 2019 Mar;37(3):459-466. doi: 10.1097/HJH.0000000000002039. Erratum In: J Hypertens. 2020 Mar;38(3):561.</citation>
    <PMID>30702492</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04506333
org study id: 1017
nct id: NCT04506333
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will determine if the A&D UA-651 blood pressure monitor is valid in children.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: The ISO/ESH/AAMI standards for validating blood pressure measurement devices will be used. In this model, participants' blood pressures are taken alternating between the test device and a reference device.
primary purpose: Other
masking: None (Open Label)
masking description: Investigators and assessors will need to know which device is associated with each measurement to perform analysis as specified in ISO/ESH/AAMI standards, but observers taking manual reference blood pressure measurements will be blinded as to each other's measurements.
measure: Blood Pressure Triplet
time frame: Immediate
description: A valid set of 3 measurements (reference-test-reference) will be considered one outcome measurement for validation.
arm group label: Small Cuff
arm group type: Experimental
description: Participants with an upper-arm circumference of 6.3-9.4" may be placed in the small cuff arm.
arm group label: Medium Cuff
arm group type: Experimental
description: Participants with an upper-arm circumference of 9.0-14.6" may be placed in the medium cuff arm.
arm group label: Lage Cuff
arm group type: Experimental
description: Participants with an upper-arm circumference of 12.2-17.7" may be placed in the large cuff arm.
The large cuff arm will use an adaptive study design. Per the AAMI/ESH/ISO standards, at least 1/6 of participants must fall into each cuff size arm for that cuff size, and of the participants assigned to each cuff size, at least 40% of those must fall in the upper and lower half of the cuff's size range. However, we do not anticipate many participants in our age range falling in the upper half of the large cuff size range (upper arm circumference > 14.95").
Because of this, our plan is to validate the large cuff, but if enrolling a patient with a large cuff would require additional patients be enrolled to reach 1/6 of the total sample, the large cuff will be dropped from consideration and the validation completed with only the small and medium cuffs.
intervention type: Device
intervention name: A&D UA-651 Blood Pressure Monitor
description: Test device to be validated.
arm group label: Lage Cuff
arm group label: Medium Cuff
arm group label: Small Cuff
intervention type: Device
intervention name: ADC 740-N Manual Sphygmomanometer
description: Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.
arm group label: Lage Cuff
arm group label: Medium Cuff
arm group label: Small Cuff
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bryan J Donald, PharmD
role: Principal Investigator
affiliation: University of Louisiana Monroe
last name: Bryan J Donald, PharmD
phone: 318-342-1903
email: donald@ulm.edu
last name: Jessica Brady, PharmD
phone: 318-342-1697
email: brady@ulm.edu
facility: 
contact: 
country: United States
citation: Stergiou GS, Palatini P, Asmar R, Ioannidis JP, Kollias A, Lacy P, McManus RJ, Myers MG, Parati G, Shennan A, Wang J, O'Brien E; European Society of Hypertension Working Group on Blood Pressure Monitoring. Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO). J Hypertens. 2019 Mar;37(3):459-466. doi: 10.1097/HJH.0000000000002039. Erratum In: J Hypertens. 2020 Mar;38(3):561.
PMID: 30702492
responsible party type: Sponsor