<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/NCT03004157</url>
  </required_header>
  <id_info>
    <org_study_id>Infant11/2016</org_study_id>
    <nct_id>NCT03004157</nct_id>
  </id_info>
  <brief_title>Infant Chest Compression</brief_title>
  <official_title>A Randomized Comparison of Three Chest Compression Techniques and Associated Hemodynamic Effect During Infant CPR: a Randomized Manikin Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jacek Smereka</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Antonio Rodríguez-Núñez</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jerzy R Ladny</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Steve Leung</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kurt Ruetzler</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring&#xD;
      effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs&#xD;
      in the United States annually. Only 8% of the patients survive to hospital discharge and of&#xD;
      these, up to two-thirds have neurological sequelae. Majority of pediatric cardiac arrest are&#xD;
      below age of two and have poorer chance of survival versus older children&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>systolic blood pressure</measure>
    <time_frame>1 day</time_frame>
    <description>The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>diastolic blood pressure</measure>
    <time_frame>1 day</time_frame>
    <description>The blood measurement system was calibrated before each CPR setting and blood pressure including diastolic blood pressure (DBP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean arterial pressure</measure>
    <time_frame>1 day</time_frame>
    <description>The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Cardiopulmonary Arrest</condition>
  <arm_group>
    <arm_group_label>Two finger technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two finger technique TFT: the pediatric thorax is compressed with the tips of two fingers and is recommended for lone rescuer during infant CPR by international CPR guidelines</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two thumb technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two thumb technique TTHT: the two thumbs of the rescuer are placed over the lower third of the sternum, with the fingers encircling the torso and supporting the back. This technique is recommended for two rescuers during infant CPR by international CPR guidelines</description>
  </arm_group>
  <arm_group>
    <arm_group_label>new two-thumb technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>new two-thumb technique' (nTTT): this technique consists in using two thumbs directed at the angle of 90 degrees to the chest while closing the fingers of both hands in a fist</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiopulmonary resuscitation</intervention_name>
    <description>CPR for 10 minutes with a chest compression: ventilation ratio of 15:2 according to international CPR guidelines</description>
    <arm_group_label>Two finger technique</arm_group_label>
    <arm_group_label>Two thumb technique</arm_group_label>
    <arm_group_label>new two-thumb technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  active paramedics&#xD;
&#xD;
          -  voluntary consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  back pain&#xD;
&#xD;
          -  wrist pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Warsaw, Department of Emergency Medicine</name>
      <address>
        <city>Warsaw</city>
        <state>Masovia</state>
        <zip>02-005</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Łukasz Szarpak</investigator_full_name>
    <investigator_title>PhD, DPH, EMT-P</investigator_title>
  </responsible_party>
  <keyword>infant</keyword>
  <keyword>cardiopulmonary resuscitation</keyword>
  <keyword>hemodynamics</keyword>
  <keyword>chest compressions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03004157
org study id: Infant11/2016
nct id: NCT03004157
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring
      effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs
      in the United States annually. Only 8% of the patients survive to hospital discharge and of
      these, up to two-thirds have neurological sequelae. Majority of pediatric cardiac arrest are
      below age of two and have poorer chance of survival versus older children
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: systolic blood pressure
time frame: 1 day
description: The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP)
measure: diastolic blood pressure
time frame: 1 day
description: The blood measurement system was calibrated before each CPR setting and blood pressure including diastolic blood pressure (DBP)
measure: mean arterial pressure
time frame: 1 day
description: The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP)
arm group label: Two finger technique
arm group type: Experimental
description: Two finger technique TFT: the pediatric thorax is compressed with the tips of two fingers and is recommended for lone rescuer during infant CPR by international CPR guidelines
arm group label: Two thumb technique
arm group type: Experimental
description: Two thumb technique TTHT: the two thumbs of the rescuer are placed over the lower third of the sternum, with the fingers encircling the torso and supporting the back. This technique is recommended for two rescuers during infant CPR by international CPR guidelines
arm group label: new two-thumb technique
arm group type: Experimental
description: new two-thumb technique' (nTTT): this technique consists in using two thumbs directed at the angle of 90 degrees to the chest while closing the fingers of both hands in a fist
intervention type: Procedure
intervention name: cardiopulmonary resuscitation
description: CPR for 10 minutes with a chest compression: ventilation ratio of 15:2 according to international CPR guidelines
arm group label: Two finger technique
arm group label: Two thumb technique
arm group label: new two-thumb technique
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Łukasz Szarpak
investigator title: PhD, DPH, EMT-P
mesh term: Heart Arrest
sharing ipd: Undecided