<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/NCT03773861</url>
  </required_header>
  <id_info>
    <org_study_id>Req- 2017- 00577</org_study_id>
    <nct_id>NCT03773861</nct_id>
  </id_info>
  <brief_title>Group Size in Basic Life Support (BLS) Courses</brief_title>
  <official_title>Determining a Threshold for the Clinical and Cost-effectiveness of Group Size During Basic Life Support Courses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      Basic Life Support (BLS) is important for outcome in cardiac arrest.Therefore, it is crucial&#xD;
      to improve the quality of education in resuscitation training. Better training will&#xD;
      eventually lead to more effective CPR skills in course participants. BLS courses in both&#xD;
      international resuscitation associations (European Resuscitation Council and American Heart&#xD;
      Association are typically taught in small groups of 6 participants. In reality group sizes of&#xD;
      up to 10 participants are used, because these courses are highly demanded and cost intensive.&#xD;
      There is no evidence for the effective group size to be clinical and cost effective.&#xD;
      Therefore the investigators perform this prospective study to determine the maximum number of&#xD;
      participants an instructor can oversee without missing more than 20% of errors made during an&#xD;
      instructional BLS session.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The threshold of number of course participants in a BLS educational session</measure>
    <time_frame>BLS educational session 10 minutes</time_frame>
    <description>How many volunteers can be overseen by one instructor who still is able to correctly identify and correct serious BLS errors of all course participants.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Educational Problems</condition>
  <condition>Resuscitation</condition>
  <arm_group>
    <arm_group_label>Participants</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Active BLS- Instructors at the Bern Simulation and CPR- Center (BeSiC), at the Bern University Hospital, Bern, Switzerland. Participants have to oversee a BLS instructional session, where standardized errors are performed by trained volunteers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>errors made in one BLS session</intervention_name>
    <description>BLS instructors have to oversee a standardized BLS training session, where standardized errors are made by trained volunteers.</description>
    <arm_group_label>Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active BLS- Instructors at the Bern Simulation and CPR-Center (BeSiC), at the Bern&#xD;
             University Hospital, Bern, Switzerland&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Decline to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sabine Nabecker, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Bern, Bern, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Bern</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.</citation>
    <PMID>26477420</PMID>
  </reference>
  <reference>
    <citation>Beck S, Issleib M, Daubmann A, Zollner C. Peer education for BLS-training in schools? Results of a randomized-controlled, noninferiority trial. Resuscitation. 2015 Sep;94:85-90. doi: 10.1016/j.resuscitation.2015.06.026. Epub 2015 Jul 14.</citation>
    <PMID>26184655</PMID>
  </reference>
  <reference>
    <citation>Cendan JC, Silver M, Ben-David K. Changing the student clerkship from traditional lectures to small group case-based sessions benefits the student and the faculty. J Surg Educ. 2011 Mar-Apr;68(2):117-20. doi: 10.1016/j.jsurg.2010.09.011.</citation>
    <PMID>21338967</PMID>
  </reference>
  <reference>
    <citation>Chamberlain DA, Hazinski MF; European Resuscitation Council; American Heart Association; Heart and Stroke Foundation of Canada; Resuscitation Council of Southern Africa; Australia and New Zealand Resuscitation Council; Consejo Latino-Americano de Resusucitacion. Education in resuscitation: an ILCOR symposium: Utstein Abbey: Stavanger, Norway: June 22-24, 2001. Circulation. 2003 Nov 18;108(20):2575-94. doi: 10.1161/01.CIR.0000099898.11954.3B. No abstract available.</citation>
    <PMID>14623795</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03773861
org study id: Req- 2017- 00577
nct id: NCT03773861
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Basic Life Support (BLS) is important for outcome in cardiac arrest.Therefore, it is crucial
      to improve the quality of education in resuscitation training. Better training will
      eventually lead to more effective CPR skills in course participants. BLS courses in both
      international resuscitation associations (European Resuscitation Council and American Heart
      Association are typically taught in small groups of 6 participants. In reality group sizes of
      up to 10 participants are used, because these courses are highly demanded and cost intensive.
      There is no evidence for the effective group size to be clinical and cost effective.
      Therefore the investigators perform this prospective study to determine the maximum number of
      participants an instructor can oversee without missing more than 20% of errors made during an
      instructional BLS session.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: The threshold of number of course participants in a BLS educational session
time frame: BLS educational session 10 minutes
description: How many volunteers can be overseen by one instructor who still is able to correctly identify and correct serious BLS errors of all course participants.
arm group label: Participants
arm group type: Other
description: Active BLS- Instructors at the Bern Simulation and CPR- Center (BeSiC), at the Bern University Hospital, Bern, Switzerland. Participants have to oversee a BLS instructional session, where standardized errors are performed by trained volunteers.
intervention type: Other
intervention name: errors made in one BLS session
description: BLS instructors have to oversee a standardized BLS training session, where standardized errors are made by trained volunteers.
arm group label: Participants
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sabine Nabecker, M.D.
role: Principal Investigator
affiliation: University Hospital Bern, Bern, Switzerland
facility: 
country: Switzerland
citation: Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.
PMID: 26477420
citation: Beck S, Issleib M, Daubmann A, Zollner C. Peer education for BLS-training in schools? Results of a randomized-controlled, noninferiority trial. Resuscitation. 2015 Sep;94:85-90. doi: 10.1016/j.resuscitation.2015.06.026. Epub 2015 Jul 14.
PMID: 26184655
citation: Cendan JC, Silver M, Ben-David K. Changing the student clerkship from traditional lectures to small group case-based sessions benefits the student and the faculty. J Surg Educ. 2011 Mar-Apr;68(2):117-20. doi: 10.1016/j.jsurg.2010.09.011.
PMID: 21338967
citation: Chamberlain DA, Hazinski MF; European Resuscitation Council; American Heart Association; Heart and Stroke Foundation of Canada; Resuscitation Council of Southern Africa; Australia and New Zealand Resuscitation Council; Consejo Latino-Americano de Resusucitacion. Education in resuscitation: an ILCOR symposium: Utstein Abbey: Stavanger, Norway: June 22-24, 2001. Circulation. 2003 Nov 18;108(20):2575-94. doi: 10.1161/01.CIR.0000099898.11954.3B. No abstract available.
PMID: 14623795
responsible party type: Sponsor
sharing ipd: Undecided