<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/NCT04493970</url>
  </required_header>
  <id_info>
    <org_study_id>KCHRF-High School Musical-0005</org_study_id>
    <nct_id>NCT04493970</nct_id>
  </id_info>
  <brief_title>HS Students Mandatory Universal Student Instruction in CPR Appraised Learning- Is the Mandate Working?</brief_title>
  <official_title>Assessment of Factors Impacting High School Students Mandatory Universal Student Instruction in Cardiopulmonary Resuscitation Appraised Learning- Is the Mandate Working? (The High School MUSICAL Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kansas City Heart Rhythm Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kansas City Heart Rhythm Research Foundation</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 help to provide better input to state health and education departments to&#xD;
      improve the processes for CPR education. This will also help the EP council explore the&#xD;
      opportunities to partner with other professional societies and other stake holders that have&#xD;
      interest in this topic. Engagement of private-public partnerships for improving overall CPR&#xD;
      education.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Schools should incorporate CPR education programs in the schools that will increase the&#xD;
      knowledge, skills and awareness among high school children. It is important to note that, CPR&#xD;
      training of young children, increases the self confidence, esteem, responsibility and&#xD;
      contribution to their community.Moreover, it is clearly shown that, high school children has&#xD;
      the required physical strength, maturity and positive attitude towards performing CPR in&#xD;
      family members, friends and strangers in the community. Although some studies suggest benefit&#xD;
      of periodic retraining, few studies have attempted to collectively identify contributing&#xD;
      factors to comprehension.It is an attempt to identify national distribution of training&#xD;
      efforts and factors implicated in comprehension among high school students.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 26, 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To assess retention, effectiveness and factors impacting comprehension of cardiopulmonary resuscitation (CPR) training among high school students.</measure>
    <time_frame>7 months</time_frame>
    <description>To assess retention, effectiveness and factors impacting comprehension of cardiopulmonary resuscitation (CPR) training among high school students.</description>
  </primary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Sudden Cardiac Arrest</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High School Students Survey</intervention_name>
    <description>To assess retention, effectiveness and factors impacting comprehension of cardiopulmonary resuscitation (CPR) training among high school students.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        High school students to whom survey is distributed. Males and females will be enrolled if&#xD;
        they meet the inclusion/exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High school students completing voluntary survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give consent&#xD;
&#xD;
          -  Inability to complete survey&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dhanunjaya Lakkireddy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas City Heart Rhythm Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Donita Atkins</last_name>
    <phone>816-651-1969</phone>
    <email>datkins@kchrf.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kansas City Heart Rhythm Institute</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donita Atkins</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Sudden Cardiac Arrest Foundation. 2017. Sudden cardiac arrest: A healthcare crisis. Retrieved from http://www.scaaware.org/about-sca</citation>
  </reference>
  <reference>
    <citation>Carragher, R., Johnson, J., &amp; Harder, M. (2017). Factors that influence bystander CPR: A narrative review. International Journal of Current Research, 9(6), 52100- 52103</citation>
  </reference>
  <reference>
    <citation>Swor R, Khan I, Domeier R, Honeycutt L, Chu K, Compton S. CPR training and CPR performance: do CPR-trained bystanders perform CPR? Acad Emerg Med. 2006 Jun;13(6):596-601. doi: 10.1197/j.aem.2005.12.021. Epub 2006 Apr 13.</citation>
    <PMID>16614455</PMID>
  </reference>
  <reference>
    <citation>American Heart Association. I. CPR in schools. [cited 2019 November 29]; available from: http://cpr.heart.org/AHAECC/CPRAndECC/Programs/CPRInSchools/UCM_475820_ CPR-in-Schools-Legislation-Map.jsp; 2016</citation>
  </reference>
  <reference>
    <citation>Brown LE, Carroll T, Lynes C, Tripathi A, Halperin H, Dillon WC. CPR skill retention in 795 high school students following a 45-minute course with psychomotor practice. Am J Emerg Med. 2018 Jun;36(6):1110-1112. doi: 10.1016/j.ajem.2017.10.026. Epub 2017 Oct 13. No abstract available.</citation>
    <PMID>29055618</PMID>
  </reference>
  <reference>
    <citation>Cave DM, Aufderheide TP, Beeson J, Ellison A, Gregory A, Hazinski MF, Hiratzka LF, Lurie KG, Morrison LJ, Mosesso VN Jr, Nadkarni V, Potts J, Samson RA, Sayre MR, Schexnayder SM; American Heart Association Emergency Cardiovascular Care Committee; Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular Diseases in the Young; Council on Cardiovascular Nursing; Council on Clinical Cardiology, and Advocacy Coordinating Committee. Importance and implementation of training in cardiopulmonary resuscitation and automated external defibrillation in schools: a science advisory from the American Heart Association. Circulation. 2011 Feb 15;123(6):691-706. doi: 10.1161/CIR.0b013e31820b5328. Epub 2011 Jan 10. No abstract available.</citation>
    <PMID>21220728</PMID>
  </reference>
  <reference>
    <citation>Bernardo LM, Doyle C, Bryn S. Basic emergency lifesaving skills (BELS): a framework for teaching skills to children and adolescents. Int J Trauma Nurs. 2002 Apr-Jun;8(2):48-50. doi: 10.1067/mtn.2002.123027. No abstract available.</citation>
    <PMID>12000907</PMID>
  </reference>
  <reference>
    <citation>Parnell MM, Pearson J, Galletly DC, Larsen PD. Knowledge of and attitudes towards resuscitation in New Zealand high-school students. Emerg Med J. 2006 Dec;23(12):899-902. doi: 10.1136/emj.2006.041160.</citation>
    <PMID>17130593</PMID>
  </reference>
  <reference>
    <citation>Awwma Ma, A, Kl W, Ayl T, L Vyas, J Wilks. CPR knowledge and attitudes among high school students aged 15-16in Hong Kong. Hong Journal of Emergency Medicine Vol 22, Issue 1, 2015</citation>
  </reference>
  <reference>
    <citation>Chung CH. Extending cardiopulmonary resuscitation training to schools. Hong Kong J Emerg Med 2007;14:(3):131-3</citation>
  </reference>
  <reference>
    <citation>Oschatz E, Wunderbaldinger P, Sterz F, Holzer M, Kofler J, Slatin H, Janata K, Eisenburger P, Bankier AA, Laggner AN. Cardiopulmonary resuscitation performed by bystanders does not increase adverse effects as assessed by chest radiography. Anesth Analg. 2001 Jul;93(1):128-33. doi: 10.1097/00000539-200107000-00027.</citation>
    <PMID>11429353</PMID>
  </reference>
  <reference>
    <citation>Mejicano GC, Maki DG. Infections acquired during cardiopulmonary resuscitation: estimating the risk and defining strategies for prevention. Ann Intern Med. 1998 Nov 15;129(10):813-28. doi: 10.7326/0003-4819-129-10-199811150-00014.</citation>
    <PMID>9841588</PMID>
  </reference>
  <reference>
    <citation>Nabou L. Medico legal aspect of bystander CPR. Paper presented at the Hong Kong Resuscitation Council 2nd Annual Scientific Meeting, Hong Kong, 13 July 2013</citation>
  </reference>
  <reference>
    <citation>Uhm TH, Oh JK, Park JH, Yang SJ, Kim JH.Correlation between physical features of elementary school children and chest compression depth. Hong Kong J Emerg Med 2010;17(3):218-23</citation>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CPR Education</keyword>
  <keyword>High School Students</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04493970
org study id: KCHRF-High School Musical-0005
nct id: NCT04493970
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will help to provide better input to state health and education departments to
      improve the processes for CPR education. This will also help the EP council explore the
      opportunities to partner with other professional societies and other stake holders that have
      interest in this topic. Engagement of private-public partnerships for improving overall CPR
      education.
Schools should incorporate CPR education programs in the schools that will increase the
      knowledge, skills and awareness among high school children. It is important to note that, CPR
      training of young children, increases the self confidence, esteem, responsibility and
      contribution to their community.Moreover, it is clearly shown that, high school children has
      the required physical strength, maturity and positive attitude towards performing CPR in
      family members, friends and strangers in the community. Although some studies suggest benefit
      of periodic retraining, few studies have attempted to collectively identify contributing
      factors to comprehension.It is an attempt to identify national distribution of training
      efforts and factors implicated in comprehension among high school students.
observational model: Other
time perspective: Prospective
measure: To assess retention, effectiveness and factors impacting comprehension of cardiopulmonary resuscitation (CPR) training among high school students.
time frame: 7 months
description: To assess retention, effectiveness and factors impacting comprehension of cardiopulmonary resuscitation (CPR) training among high school students.
intervention type: Other
intervention name: High School Students Survey
description: To assess retention, effectiveness and factors impacting comprehension of cardiopulmonary resuscitation (CPR) training among high school students.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 25 Years
healthy volunteers: No
last name: Dhanunjaya Lakkireddy
role: Principal Investigator
affiliation: Kansas City Heart Rhythm Institute
last name: Donita Atkins
phone: 816-651-1969
email: datkins@kchrf.com
facility: 
status: Recruiting
contact: 
country: United States
citation: Sudden Cardiac Arrest Foundation. 2017. Sudden cardiac arrest: A healthcare crisis. Retrieved from http://www.scaaware.org/about-sca
citation: Carragher, R., Johnson, J., & Harder, M. (2017). Factors that influence bystander CPR: A narrative review. International Journal of Current Research, 9(6), 52100- 52103
citation: Swor R, Khan I, Domeier R, Honeycutt L, Chu K, Compton S. CPR training and CPR performance: do CPR-trained bystanders perform CPR? Acad Emerg Med. 2006 Jun;13(6):596-601. doi: 10.1197/j.aem.2005.12.021. Epub 2006 Apr 13.
PMID: 16614455
citation: American Heart Association. I. CPR in schools. [cited 2019 November 29]; available from: http://cpr.heart.org/AHAECC/CPRAndECC/Programs/CPRInSchools/UCM_475820_ CPR-in-Schools-Legislation-Map.jsp; 2016
citation: Brown LE, Carroll T, Lynes C, Tripathi A, Halperin H, Dillon WC. CPR skill retention in 795 high school students following a 45-minute course with psychomotor practice. Am J Emerg Med. 2018 Jun;36(6):1110-1112. doi: 10.1016/j.ajem.2017.10.026. Epub 2017 Oct 13. No abstract available.
PMID: 29055618
citation: Cave DM, Aufderheide TP, Beeson J, Ellison A, Gregory A, Hazinski MF, Hiratzka LF, Lurie KG, Morrison LJ, Mosesso VN Jr, Nadkarni V, Potts J, Samson RA, Sayre MR, Schexnayder SM; American Heart Association Emergency Cardiovascular Care Committee; Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular Diseases in the Young; Council on Cardiovascular Nursing; Council on Clinical Cardiology, and Advocacy Coordinating Committee. Importance and implementation of training in cardiopulmonary resuscitation and automated external defibrillation in schools: a science advisory from the American Heart Association. Circulation. 2011 Feb 15;123(6):691-706. doi: 10.1161/CIR.0b013e31820b5328. Epub 2011 Jan 10. No abstract available.
PMID: 21220728
citation: Bernardo LM, Doyle C, Bryn S. Basic emergency lifesaving skills (BELS): a framework for teaching skills to children and adolescents. Int J Trauma Nurs. 2002 Apr-Jun;8(2):48-50. doi: 10.1067/mtn.2002.123027. No abstract available.
PMID: 12000907
citation: Parnell MM, Pearson J, Galletly DC, Larsen PD. Knowledge of and attitudes towards resuscitation in New Zealand high-school students. Emerg Med J. 2006 Dec;23(12):899-902. doi: 10.1136/emj.2006.041160.
PMID: 17130593
citation: Awwma Ma, A, Kl W, Ayl T, L Vyas, J Wilks. CPR knowledge and attitudes among high school students aged 15-16in Hong Kong. Hong Journal of Emergency Medicine Vol 22, Issue 1, 2015
citation: Chung CH. Extending cardiopulmonary resuscitation training to schools. Hong Kong J Emerg Med 2007;14:(3):131-3
citation: Oschatz E, Wunderbaldinger P, Sterz F, Holzer M, Kofler J, Slatin H, Janata K, Eisenburger P, Bankier AA, Laggner AN. Cardiopulmonary resuscitation performed by bystanders does not increase adverse effects as assessed by chest radiography. Anesth Analg. 2001 Jul;93(1):128-33. doi: 10.1097/00000539-200107000-00027.
PMID: 11429353
citation: Mejicano GC, Maki DG. Infections acquired during cardiopulmonary resuscitation: estimating the risk and defining strategies for prevention. Ann Intern Med. 1998 Nov 15;129(10):813-28. doi: 10.7326/0003-4819-129-10-199811150-00014.
PMID: 9841588
citation: Nabou L. Medico legal aspect of bystander CPR. Paper presented at the Hong Kong Resuscitation Council 2nd Annual Scientific Meeting, Hong Kong, 13 July 2013
citation: Uhm TH, Oh JK, Park JH, Yang SJ, Kim JH.Correlation between physical features of elementary school children and chest compression depth. Hong Kong J Emerg Med 2010;17(3):218-23
responsible party type: Sponsor
mesh term: Death, Sudden, Cardiac
sharing ipd: No