xml: <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/NCT06041685</url>
    </required_header>
    <id_info>
      <org_study_id>2023-06-30</org_study_id>
      <nct_id>NCT06041685</nct_id>
    </id_info>
    <brief_title>Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia</brief_title>
    <acronym>WARM-PA</acronym>
    <official_title>Effect of Local Warming for Arterial Catheterization in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pusan National University Yangsan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pusan National University Yangsan Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The increase in internal diameter (ID) and cross-sectional area (CSA) may facilitate better&#xD;
        arterial catheterization. Since an increase in body temperature can cause peripheral&#xD;
        vasodilation, we aimed to determine if local warming of the radial artery (RA)&#xD;
        catheterization site could improve the success rate of catheterization in pediatric patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This randomized, controlled study enrolls 126 pediatric patients aged ≤ 2 years who were&#xD;
        scheduled for heart surgery. They are randomized into non-warming (C) and warming (W) groups.&#xD;
        After induction, the baseline artery ultrasonography images are collected. In the warming&#xD;
        group (W), local warming is applied on the catheterization site. Before catheterization, the&#xD;
        artery ultrasonography images are collected. The primary outcome is the first-attempt success&#xD;
        rate. The secondary outcomes included the ID and CSA of the artery and overall complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>first-attempt success rate of arterial catheterization</measure>
      <time_frame>baseline, imediate after arterial catheterization</time_frame>
      <description>The first-attempt success rate of pediatric peripheral arterial catheterization in the non-warming group, or warming group</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>internal diameter (ID) and cross-sectional area (CSA)</measure>
      <time_frame>baseline, imediate after arterial catheterization in the non-warming group, or warming group</time_frame>
      <description>internal diameter (ID) and cross-sectional area (CSA)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">126</enrollment>
    <condition>Congenital Heart Disease</condition>
    <arm_group>
      <arm_group_label>Non-warming group (C)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>After induction, the baseline artery ultrasonography images are collected for the internal diameter and cross-sectional area of the artery. In the non-warming group (C), local warming is not applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. Then, arterial catheterization is applied.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Warming group (W)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the warming group (W), local warming is applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. Then, arterial catheterization is done.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>local warming</intervention_name>
      <description>local warming on the site for arterial catheterization using forced air warmer</description>
      <arm_group_label>Warming group (W)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  aged ≤ 2 years&#xD;
  &#xD;
            -  cardiac surgery with peripheral artery catheterization&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unstable vital signs&#xD;
  &#xD;
            -  pre-existing arterial catheter (exception of umbilical artery catheterization)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>2 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hee Young Kim</last_name>
      <role>Principal Investigator</role>
      <affiliation>Pusan National University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hee Young Kim</last_name>
      <phone>+82-055-360-2129</phone>
      <email>anekhy@pusan.ac.kr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Seyeon Park</last_name>
      <phone>+82-055-360-2129</phone>
      <email>chocostar@hanmail.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Pusan National University Yangsan Hospital</name>
        <address>
          <city>Yangsan</city>
          <state>Kyungnam</state>
          <zip>50612</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Seyeon Park</last_name>
        <phone>+82-055-360-2129</phone>
        <email>chocostar@hanmail.net</email>
      </contact>
      <investigator>
        <last_name>Seyeon Park</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <reference>
      <citation>Christen S, Delachaux A, Dischl B, Golay S, Liaudet L, Feihl F, Waeber B. Dose-dependent vasodilatory effects of acetylcholine and local warming on skin microcirculation. J Cardiovasc Pharmacol. 2004 Dec;44(6):659-64. doi: 10.1097/00005344-200412000-00006.</citation>
      <PMID>15550784</PMID>
    </reference>
    <reference>
      <citation>Al-Hakim R, Hedge JC, Jahangiri Y, Kaufman JA, Galuppo R, Farsad K. Palmar Warming for Radial Artery Vasodilation to Facilitate Transradial Access: A Randomized Controlled Trial. J Vasc Interv Radiol. 2019 Mar;30(3):421-424. doi: 10.1016/j.jvir.2018.10.021.</citation>
      <PMID>30819486</PMID>
    </reference>
    <reference>
      <citation>Barcroft H, Edholm OG. The effect of temperature on blood flow and deep temperature in the human forearm. J Physiol. 1943 Jun 30;102(1):5-20. doi: 10.1113/jphysiol.1943.sp004009. No abstract available.</citation>
      <PMID>16991588</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Pusan National University Yangsan Hospital</investigator_affiliation>
      <investigator_full_name>Kim Hee Young</investigator_full_name>
      <investigator_title>Fund assistant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Heart Defects, Congenital</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041685
  org study id: 2023-06-30
  nct id: NCT06041685
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The increase in internal diameter (ID) and cross-sectional area (CSA) may facilitate better
        arterial catheterization. Since an increase in body temperature can cause peripheral
        vasodilation, we aimed to determine if local warming of the radial artery (RA)
        catheterization site could improve the success rate of catheterization in pediatric patients.
  This randomized, controlled study enrolls 126 pediatric patients aged ≤ 2 years who were
        scheduled for heart surgery. They are randomized into non-warming (C) and warming (W) groups.
        After induction, the baseline artery ultrasonography images are collected. In the warming
        group (W), local warming is applied on the catheterization site. Before catheterization, the
        artery ultrasonography images are collected. The primary outcome is the first-attempt success
        rate. The secondary outcomes included the ID and CSA of the artery and overall complications.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  measure: first-attempt success rate of arterial catheterization
  time frame: baseline, imediate after arterial catheterization
  description: The first-attempt success rate of pediatric peripheral arterial catheterization in the non-warming group, or warming group
  measure: internal diameter (ID) and cross-sectional area (CSA)
  time frame: baseline, imediate after arterial catheterization in the non-warming group, or warming group
  description: internal diameter (ID) and cross-sectional area (CSA)
  arm group label: Non-warming group (C)
  arm group type: No Intervention
  description: After induction, the baseline artery ultrasonography images are collected for the internal diameter and cross-sectional area of the artery. In the non-warming group (C), local warming is not applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. Then, arterial catheterization is applied.
  arm group label: Warming group (W)
  arm group type: Experimental
  description: In the warming group (W), local warming is applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. Then, arterial catheterization is done.
  intervention type: Procedure
  intervention name: local warming
  description: local warming on the site for arterial catheterization using forced air warmer
  arm group label: Warming group (W)
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 2 Years
  healthy volunteers: No
  last name: Hee Young Kim
  role: Principal Investigator
  affiliation: Pusan National University
  last name: Hee Young Kim
  phone: +82-055-360-2129
  email: anekhy@pusan.ac.kr
  last name: Seyeon Park
  phone: +82-055-360-2129
  email: chocostar@hanmail.net
  facility: 
  contact: 
  investigator: 
  country: Korea, Republic of
  citation: Christen S, Delachaux A, Dischl B, Golay S, Liaudet L, Feihl F, Waeber B. Dose-dependent vasodilatory effects of acetylcholine and local warming on skin microcirculation. J Cardiovasc Pharmacol. 2004 Dec;44(6):659-64. doi: 10.1097/00005344-200412000-00006.
  PMID: 15550784
  citation: Al-Hakim R, Hedge JC, Jahangiri Y, Kaufman JA, Galuppo R, Farsad K. Palmar Warming for Radial Artery Vasodilation to Facilitate Transradial Access: A Randomized Controlled Trial. J Vasc Interv Radiol. 2019 Mar;30(3):421-424. doi: 10.1016/j.jvir.2018.10.021.
  PMID: 30819486
  citation: Barcroft H, Edholm OG. The effect of temperature on blood flow and deep temperature in the human forearm. J Physiol. 1943 Jun 30;102(1):5-20. doi: 10.1113/jphysiol.1943.sp004009. No abstract available.
  PMID: 16991588
  responsible party type: Principal Investigator
  investigator affiliation: Pusan National University Yangsan Hospital
  investigator full name: Kim Hee Young
  investigator title: Fund assistant professor
  mesh term: Heart Diseases
  mesh term: Heart Defects, Congenital
  sharing ipd: Undecided