<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/NCT04478786</url>
  </required_header>
  <id_info>
    <org_study_id>18018/275607</org_study_id>
    <nct_id>NCT04478786</nct_id>
  </id_info>
  <brief_title>Ambulance Crews' Experiences of Using a Mechanical Chest Compression Device.</brief_title>
  <official_title>What Are Ambulance Crews' Experiences of Using a Mechanical Chest Compression Device for Out-of-hospital Resuscitation? A Constructivist Qualitative Study Utilising Online Focus Groups</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northumbria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jolife AB</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Northumbria University</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>
      Should a person have a cardiac arrest (where their heart stops beating) they require&#xD;
      treatment of cardiopulmonary resuscitation (CPR). This includes providing chest compressions.&#xD;
      Traditionally these compressions are provided by hand but mechanical chest compression&#xD;
      devices (MCCD) have been investigated for use in out of hospital resuscitation attempts.&#xD;
&#xD;
      Research trials recruiting human participants have concluded recently. They all found no&#xD;
      difference in survival outcomes when MCCD and manual compressions were compared.&#xD;
&#xD;
      Despite this, the latest expert review on MCCD suggests that MCCD can be a reasonable&#xD;
      alternative to high quality manual compressions when these cannot be provided. MCCD continue&#xD;
      to be used by Specialists in the local ambulance service and historically by those recruiting&#xD;
      patients to a national multi centre trial of MCCD. There is another, as yet&#xD;
      under-investigated element, and that is of ambulance crews' experiences of using such&#xD;
      devices. Therefore it is a reasonable topic to investigate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will invite local United Kingdom (UK) National Health Service (NHS) operational&#xD;
      ambulance crews to participate in a 1-2 hour online focus group discussion (a collective&#xD;
      group discussion) about their experiences of using MCCD. The participants will be any&#xD;
      operational ambulance crew member, employed by the local ambulance Trust and who had&#xD;
      experience of using any type of MCCD. The focus groups will be audio recorded; participants&#xD;
      will be aware of this when they choose to participate.&#xD;
&#xD;
      The aim of this research is to collect and report ambulance crews' experiences of using&#xD;
      mechanical chest compression devices for out of hospital resuscitation attempts.&#xD;
&#xD;
      Ultimately there may of course be benefits for patients by exploring whether MCCD play a part&#xD;
      in out of hospital resuscitations. Funding has been offered by a manufacturer one of the&#xD;
      types of MCCD; they have had no involvement in the design or analysis of the study.&#xD;
&#xD;
      Once transcribed, the data will be analysed manually. The content of each focus group will be&#xD;
      coded and then each participants' individual responses will be coded, first using open&#xD;
      coding, then focused coding to identify emergent themes, before concluding with the&#xD;
      categories that have been identified. The constant comparison method of data analysis will be&#xD;
      used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Actual">September 19, 2020</completion_date>
  <primary_completion_date type="Actual">September 19, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Collect and report ambulance crews' experiences of using MCCDs for out-of-hospital resuscitation attempts.</measure>
    <time_frame>2 hours</time_frame>
    <description>The transcribed discussions will be coded and then themes emerging from the data identified and developed. To do this I will use a constant comparison method of analysis. The presence or lack of consensus and reinforcement on certain topics will also be observed for.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Does the use of MCCDs have any effect on, or facilitate, the team leader role at an out-of-hospital resuscitation attempt</measure>
    <time_frame>2 hours</time_frame>
    <description>The transcribed discussions will be coded and then themes emerging from the data identified and developed. To do this I will use a constant comparison method of analysis. The presence or lack of consensus and reinforcement on certain topics will also be observed for.</description>
  </other_outcome>
  <other_outcome>
    <measure>Does providing mechanical versus manual chest compressions have an effect on how ambulance crews feel physically and emotionally after an out-of-hospital resuscitation attempt.</measure>
    <time_frame>2 hours</time_frame>
    <description>The transcribed discussions will be coded and then themes emerging from the data identified and developed. To do this I will use a constant comparison method of analysis. The presence or lack of consensus and reinforcement on certain topics will also be observed for.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Resuscitation</condition>
  <arm_group>
    <arm_group_label>Focus Groups 1-4</arm_group_label>
    <description>An anticipated 3-8 participants who meet the inclusion criteria of being aged 18 or over, a employee of the local ambulance service, are employed as an operational ambulance crew member, irrespective of title and to have had experienced an out of hospital resuscitation where MCCD was used, irrespective of the type of device or their level of involvement, and who also volunteer and agree to take part in the online focus group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Focus group discussion</intervention_name>
    <description>There is no intervention. This is a qualitative piece of work only.</description>
    <arm_group_label>Focus Groups 1-4</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Operational ambulance crew employees of the local ambulance service&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18 or over&#xD;
&#xD;
          -  an employee of the local ambulance service&#xD;
&#xD;
          -  employed as an operational ambulance crew member, irrespective of title&#xD;
&#xD;
          -  to have experienced an out of hospital resuscitation where MCCD was used, irrespective&#xD;
             of the type of device or their level of involvement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not an employee of the local ambulance service&#xD;
&#xD;
          -  have no experience of using a mechanical chest compression device at an out of&#xD;
             hospital resuscitation&#xD;
&#xD;
          -  the participant is unwilling to provide consent to participate&#xD;
&#xD;
          -  the participant is unwilling to provide consent to be audio recorded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Richelle Duffy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northumbria University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North East Ambulance Service NHS Foundation Trust</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE15 8NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Blair L, Duffy R. What are ambulance crews' experiences of using a mechanical chest compression device for out-of-hospital resuscitation? A constructivist qualitative study utilising online focus groups. Br Paramed J. 2022 Sep 1;7(2):24-30. doi: 10.29045/14784726.2022.09.7.2.24.</citation>
    <PMID>36451709</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>October 11, 2022</last_update_submitted>
  <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiopulmonary Resuscitation,</keyword>
  <keyword>Resuscitation</keyword>
  <keyword>Out of Hospital</keyword>
  <keyword>Ambulance Crew</keyword>
  <keyword>Mechanical Chest Compression Device</keyword>
  <keyword>Qualitative</keyword>
  <keyword>Experiences</keyword>
  <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/NCT04478786
org study id: 18018/275607
nct id: NCT04478786
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Should a person have a cardiac arrest (where their heart stops beating) they require
      treatment of cardiopulmonary resuscitation (CPR). This includes providing chest compressions.
      Traditionally these compressions are provided by hand but mechanical chest compression
      devices (MCCD) have been investigated for use in out of hospital resuscitation attempts.

      Research trials recruiting human participants have concluded recently. They all found no
      difference in survival outcomes when MCCD and manual compressions were compared.

      Despite this, the latest expert review on MCCD suggests that MCCD can be a reasonable
      alternative to high quality manual compressions when these cannot be provided. MCCD continue
      to be used by Specialists in the local ambulance service and historically by those recruiting
      patients to a national multi centre trial of MCCD. There is another, as yet
      under-investigated element, and that is of ambulance crews' experiences of using such
      devices. Therefore it is a reasonable topic to investigate.
This study will invite local United Kingdom (UK) National Health Service (NHS) operational
      ambulance crews to participate in a 1-2 hour online focus group discussion (a collective
      group discussion) about their experiences of using MCCD. The participants will be any
      operational ambulance crew member, employed by the local ambulance Trust and who had
      experience of using any type of MCCD. The focus groups will be audio recorded; participants
      will be aware of this when they choose to participate.

      The aim of this research is to collect and report ambulance crews' experiences of using
      mechanical chest compression devices for out of hospital resuscitation attempts.

      Ultimately there may of course be benefits for patients by exploring whether MCCD play a part
      in out of hospital resuscitations. Funding has been offered by a manufacturer one of the
      types of MCCD; they have had no involvement in the design or analysis of the study.

      Once transcribed, the data will be analysed manually. The content of each focus group will be
      coded and then each participants' individual responses will be coded, first using open
      coding, then focused coding to identify emergent themes, before concluding with the
      categories that have been identified. The constant comparison method of data analysis will be
      used.
observational model: Other
time perspective: Retrospective
measure: Collect and report ambulance crews' experiences of using MCCDs for out-of-hospital resuscitation attempts.
time frame: 2 hours
description: The transcribed discussions will be coded and then themes emerging from the data identified and developed. To do this I will use a constant comparison method of analysis. The presence or lack of consensus and reinforcement on certain topics will also be observed for.
measure: Does the use of MCCDs have any effect on, or facilitate, the team leader role at an out-of-hospital resuscitation attempt
time frame: 2 hours
description: The transcribed discussions will be coded and then themes emerging from the data identified and developed. To do this I will use a constant comparison method of analysis. The presence or lack of consensus and reinforcement on certain topics will also be observed for.
measure: Does providing mechanical versus manual chest compressions have an effect on how ambulance crews feel physically and emotionally after an out-of-hospital resuscitation attempt.
time frame: 2 hours
description: The transcribed discussions will be coded and then themes emerging from the data identified and developed. To do this I will use a constant comparison method of analysis. The presence or lack of consensus and reinforcement on certain topics will also be observed for.
arm group label: Focus Groups 1-4
description: An anticipated 3-8 participants who meet the inclusion criteria of being aged 18 or over, a employee of the local ambulance service, are employed as an operational ambulance crew member, irrespective of title and to have had experienced an out of hospital resuscitation where MCCD was used, irrespective of the type of device or their level of involvement, and who also volunteer and agree to take part in the online focus group.
intervention type: Other
intervention name: Focus group discussion
description: There is no intervention. This is a qualitative piece of work only.
arm group label: Focus Groups 1-4
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Richelle Duffy, PhD
role: Principal Investigator
affiliation: Northumbria University
facility: 
country: United Kingdom
citation: Blair L, Duffy R. What are ambulance crews' experiences of using a mechanical chest compression device for out-of-hospital resuscitation? A constructivist qualitative study utilising online focus groups. Br Paramed J. 2022 Sep 1;7(2):24-30. doi: 10.29045/14784726.2022.09.7.2.24.
PMID: 36451709
responsible party type: Sponsor
sharing ipd: No