<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/NCT03017144</url>
  </required_header>
  <id_info>
    <org_study_id>T70/2012</org_study_id>
    <nct_id>NCT03017144</nct_id>
  </id_info>
  <brief_title>The Association Between Technical and Non-technical Skills in Real-life ALS Situations. Impact of Pit Crew Model on the Resuscitation Skills.</brief_title>
  <official_title>The Association Between Technical and Non-technical Skills in Real-life ALS Situations. Impact of Pit Crew Model on the Resuscitation Skills.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Turku University Hospital</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>
      Cardiac arrest is handled by cardiopulmonary resuscitation which is a time critical emergency&#xD;
      situation. The actions during resuscitation are lead by international guidelines.&#xD;
      Traditionally, the main focus of the training has been on medical knowledge and technical&#xD;
      skills (TS). Nowadays non-technical skills (NTS), such as communication, teamwork behaviour,&#xD;
      and leadership, are considered at least equally important.&#xD;
&#xD;
      The aim of this study is to evaluate both TS and NTS of the resuscitation team during&#xD;
      real-life resuscitation situations using a validated assessment tool. The association between&#xD;
      TS and NTS will be analyzed. Findings from this study may help to recognize the possible&#xD;
      weaknesses and issues which could be improved by training. Hypothesis is that that TS are&#xD;
      probably in a high level, but some improvement points of NTS are ought to be known better.&#xD;
      Investigators hypothesis that the good NTS performance in resuscitation is accompanied by&#xD;
      good TS performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Cardiac arrest is a time-critical emergency situation, which is treated by cardiopulmonary&#xD;
      resuscitation (CPR). The actions during resuscitation are lead by international guidelines&#xD;
      (Nolan et al 2010). Because of the relatively rare nature of cardiac arrests in many wards&#xD;
      and clinics, regular resuscitation training is necessary.&#xD;
&#xD;
      During cardiopulmonary resuscitation and other sudden medical crisis situations, in addition&#xD;
      to medical knowledge and technical skills (TS), also non-technical skills (NTS) are needed&#xD;
      (Castelao et al 2011, Fletcher et al 2002, Helmreich et al 1999, Gaba et al 1998). NTS are&#xD;
      behavioural elements which are ought to improve team performance. The importance of NTS has&#xD;
      been demonstrated only in a simulated settings, not in a real life.&#xD;
&#xD;
      Drawbacks in team organization and communication are frequent problems within advanced life&#xD;
      support (ALS) events (Risaliti et al, Colquitt et al). As unclear team member roles can cause&#xD;
      errors during ALS (Weng et al, Ornato et al) more emphasis should be placed on educating&#xD;
      specific roles and responsibilities to resuscitation team members (Soar et al, Maney et al).&#xD;
      Pit crew models for resuscitation, where all resuscitation team members have their&#xD;
      pre-assigned positions and pre-arranged roles and tasks to perform ALS have been developed to&#xD;
      respond these problems. (Gonzales et al, Pearson et al, Glendenning et al, Ong et al, Hopkins&#xD;
      et al, Spitzer et al)&#xD;
&#xD;
      Objective, purpose, and hypothesis&#xD;
&#xD;
      The first part of this study (ID T70/2012) aims to evaluate the technical and especially&#xD;
      non-technical skills of the resuscitation team during real-life resuscitation situations.&#xD;
      Investigators hypothesis that good non-technical performance is related on good technical&#xD;
      performance. Findings from this study may help to recognize the possible weaknesses and&#xD;
      issues which could be improved by training. The hypothesis is that technical skills are&#xD;
      probably on a high level, but some improvement points of non-technical skills are ought to be&#xD;
      known better.&#xD;
&#xD;
      The second part of the study aims to evaluate the impact of a pit crew model on ALS skills.&#xD;
      (ID: T70/2012)&#xD;
&#xD;
      Design and Methods&#xD;
&#xD;
      Turku University Central Hospital lies in a Southwestern part of Finland, and provides&#xD;
      medical services for 865 000 inhabitants. The target group of this study is the resuscitation&#xD;
      team of the adult ICU of Turku University Central Hospital. This team consists of an ICU&#xD;
      doctor (most commonly an anaesthesiologist specialized for intensive care), two ICU nurses,&#xD;
      and one medical technician. These people are treating approximately 90 cardiac arrests per&#xD;
      year, but this group also gets other alarms (like shortness of breath, unconscious patients&#xD;
      and other acute situations). This ICU resuscitation team takes care of all resuscitation&#xD;
      calls in the newer part of the Turku University Hospital, when the older parts of the&#xD;
      hospital are taken care either by a resuscitation team from pediatric ICU or by prehospital&#xD;
      emergency medical service system.&#xD;
&#xD;
      The data from 20 video-recorded real-life resuscitation situations treated by resuscitation&#xD;
      team in Turku University Hospital will be collected and the overall NTS and TS score will be&#xD;
      measured using a validated assessment tool (Peltonen et al 2017). The association between the&#xD;
      TS and NTS will be analyzed by statistical methods. In addition, after each recorded&#xD;
      resuscitation situation, every member of the resuscitation team will be called by a phone.&#xD;
      During the calls team members are asked to tell examples, what went well during the&#xD;
      resuscitation, and what could have been done better. Based on these answers, inductive&#xD;
      analysis will be made.&#xD;
&#xD;
      A pit crew model for resuscitation will be implemented in our organizations' resuscitation&#xD;
      team responding cardiac arrest alarms. We will continue to video-recording after the&#xD;
      intervention, and similarly, NTS and TS will be measured using the validated assessment tool&#xD;
      (Peltonen et al 2017). In the second part of the study, we will compare the pre- and&#xD;
      post-intervention ALS-performance in the videos.&#xD;
&#xD;
      Ethics&#xD;
&#xD;
      The study protocol was approved by the Ethics Committee of Turku University. All&#xD;
      ALS-situations in Turku University newer hospital building area are considered eligible to&#xD;
      the study regardless of the initial rhythm or presumed aetiology. Written information consent&#xD;
      of patients is not needed, because the study is directed at resuscitation team performance,&#xD;
      not the patients. The patients are not identified at any phase of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2012</start_date>
  <completion_date type="Actual">September 2020</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To measure the association of the NTS and TS on one-another using validated assessment tool.</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the association between NTS and TS subgategories.</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>To evaluate the impact of the pit crew model.</measure>
    <time_frame>two years</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Resuscitation team</arm_group_label>
    <description>Resuscitation pit crew model is educated to the resuscitation team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pit crew model education</intervention_name>
    <description>A pit crew model for resuscitation is educated to all resuscitation team members.</description>
    <arm_group_label>Resuscitation team</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The target group of this study is the resuscitation team of the adult ICU of Turku&#xD;
        University Central Hospital. This team consists of an ICU doctor (most commonly an&#xD;
        anaesthesiologist specialized for intensive care), two ICU nurses and one medical&#xD;
        technician.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. a doctor, a nurse, a paramedic or a medical technician working on adult ICU&#xD;
             resuscitation team&#xD;
&#xD;
          2. all the members of the ICU resuscitation team in the CPR-situation are volunteer to&#xD;
             take part in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) if any member of the ICU resuscitation team in the CPR-situation refuse to be video&#xD;
        recoded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miretta Tommila, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Turku University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sanna Salanterä, PhD, RN</last_name>
    <role>Study Director</role>
    <affiliation>Vice Head of the Department of Nursing Science and Nurse Director at Turku University Hospital, Finland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ville Peltonen, Lic.Med</last_name>
    <role>Study Chair</role>
    <affiliation>Turku University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laura-Maria Peltonen, M.Sc. RN</last_name>
    <role>Study Chair</role>
    <affiliation>University of Turku, Finland, Nursing Science</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Teemu Elomaa, Lic.Med</last_name>
    <role>Study Chair</role>
    <affiliation>Turku University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaana Elomaa, RN</last_name>
    <role>Study Chair</role>
    <affiliation>Turku University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tomi Pappila, RN</last_name>
    <role>Study Chair</role>
    <affiliation>Vakka-Suomi Hospital Tyks, Finland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sanna Hoppu, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Tampere University Hospital, Finland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eeva Hevonoja, RN</last_name>
    <role>Study Chair</role>
    <affiliation>University of Turku, Finland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Saija Hurme</last_name>
    <role>Study Chair</role>
    <affiliation>University of Turku, Finland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katariina Perkonoja</last_name>
    <role>Study Chair</role>
    <affiliation>University of Turku, Finland</affiliation>
  </overall_official>
  <reference>
    <citation>Nolan JP, Soar J, Zideman DA, Biarent D, Bossaert LL, Deakin C, Koster RW, Wyllie J, Bottiger B; ERC Guidelines Writing Group. European Resuscitation Council Guidelines for Resuscitation 2010 Section 1. Executive summary. Resuscitation. 2010 Oct;81(10):1219-76. doi: 10.1016/j.resuscitation.2010.08.021. No abstract available.</citation>
    <PMID>20956052</PMID>
  </reference>
  <reference>
    <citation>Fernandez Castelao E, Russo SG, Cremer S, Strack M, Kaminski L, Eich C, Timmermann A, Boos M. Positive impact of crisis resource management training on no-flow time and team member verbalisations during simulated cardiopulmonary resuscitation: a randomised controlled trial. Resuscitation. 2011 Oct;82(10):1338-43. doi: 10.1016/j.resuscitation.2011.05.009. Epub 2011 May 25.</citation>
    <PMID>21664757</PMID>
  </reference>
  <reference>
    <citation>Fletcher GC, McGeorge P, Flin RH, Glavin RJ, Maran NJ. The role of non-technical skills in anaesthesia: a review of current literature. Br J Anaesth. 2002 Mar;88(3):418-29. doi: 10.1093/bja/88.3.418. No abstract available.</citation>
    <PMID>11990277</PMID>
  </reference>
  <reference>
    <citation>Helmreich RL, Merritt AC, Wilhelm JA. The evolution of Crew Resource Management training in commercial aviation. Int J Aviat Psychol. 1999;9(1):19-32. doi: 10.1207/s15327108ijap0901_2.</citation>
    <PMID>11541445</PMID>
  </reference>
  <reference>
    <citation>Gaba DM, Howard SK, Flanagan B, Smith BE, Fish KJ, Botney R. Assessment of clinical performance during simulated crises using both technical and behavioral ratings. Anesthesiology. 1998 Jul;89(1):8-18. doi: 10.1097/00000542-199807000-00005.</citation>
    <PMID>9667288</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>October 17, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>June 4, 2021</last_update_submitted>
  <last_update_submitted_qc>June 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>non-technical skills (NTS)</keyword>
  <keyword>human factors</keyword>
  <keyword>team work</keyword>
  <keyword>Crew Resource Management / Crisis Resource Management (CRM)</keyword>
  <keyword>technical skills (TS)</keyword>
  <keyword>Cardiopulmonary resuscitation</keyword>
  <keyword>Advanced cardiac life support</keyword>
  <keyword>Pit Crew Model</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>No</sharing_ipd>
    <ipd_description>Patients treated by cardiopulmonary resuscitation (CPR) in the videos can be recognized. Video material can not be shared due to patient privacy. Other data is possible to share.</ipd_description>
  </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/NCT03017144
org study id: T70/2012
nct id: NCT03017144
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiac arrest is handled by cardiopulmonary resuscitation which is a time critical emergency
      situation. The actions during resuscitation are lead by international guidelines.
      Traditionally, the main focus of the training has been on medical knowledge and technical
      skills (TS). Nowadays non-technical skills (NTS), such as communication, teamwork behaviour,
      and leadership, are considered at least equally important.

      The aim of this study is to evaluate both TS and NTS of the resuscitation team during
      real-life resuscitation situations using a validated assessment tool. The association between
      TS and NTS will be analyzed. Findings from this study may help to recognize the possible
      weaknesses and issues which could be improved by training. Hypothesis is that that TS are
      probably in a high level, but some improvement points of NTS are ought to be known better.
      Investigators hypothesis that the good NTS performance in resuscitation is accompanied by
      good TS performance.
Background

      Cardiac arrest is a time-critical emergency situation, which is treated by cardiopulmonary
      resuscitation (CPR). The actions during resuscitation are lead by international guidelines
      (Nolan et al 2010). Because of the relatively rare nature of cardiac arrests in many wards
      and clinics, regular resuscitation training is necessary.

      During cardiopulmonary resuscitation and other sudden medical crisis situations, in addition
      to medical knowledge and technical skills (TS), also non-technical skills (NTS) are needed
      (Castelao et al 2011, Fletcher et al 2002, Helmreich et al 1999, Gaba et al 1998). NTS are
      behavioural elements which are ought to improve team performance. The importance of NTS has
      been demonstrated only in a simulated settings, not in a real life.

      Drawbacks in team organization and communication are frequent problems within advanced life
      support (ALS) events (Risaliti et al, Colquitt et al). As unclear team member roles can cause
      errors during ALS (Weng et al, Ornato et al) more emphasis should be placed on educating
      specific roles and responsibilities to resuscitation team members (Soar et al, Maney et al).
      Pit crew models for resuscitation, where all resuscitation team members have their
      pre-assigned positions and pre-arranged roles and tasks to perform ALS have been developed to
      respond these problems. (Gonzales et al, Pearson et al, Glendenning et al, Ong et al, Hopkins
      et al, Spitzer et al)

      Objective, purpose, and hypothesis

      The first part of this study (ID T70/2012) aims to evaluate the technical and especially
      non-technical skills of the resuscitation team during real-life resuscitation situations.
      Investigators hypothesis that good non-technical performance is related on good technical
      performance. Findings from this study may help to recognize the possible weaknesses and
      issues which could be improved by training. The hypothesis is that technical skills are
      probably on a high level, but some improvement points of non-technical skills are ought to be
      known better.

      The second part of the study aims to evaluate the impact of a pit crew model on ALS skills.
      (ID: T70/2012)

      Design and Methods

      Turku University Central Hospital lies in a Southwestern part of Finland, and provides
      medical services for 865 000 inhabitants. The target group of this study is the resuscitation
      team of the adult ICU of Turku University Central Hospital. This team consists of an ICU
      doctor (most commonly an anaesthesiologist specialized for intensive care), two ICU nurses,
      and one medical technician. These people are treating approximately 90 cardiac arrests per
      year, but this group also gets other alarms (like shortness of breath, unconscious patients
      and other acute situations). This ICU resuscitation team takes care of all resuscitation
      calls in the newer part of the Turku University Hospital, when the older parts of the
      hospital are taken care either by a resuscitation team from pediatric ICU or by prehospital
      emergency medical service system.

      The data from 20 video-recorded real-life resuscitation situations treated by resuscitation
      team in Turku University Hospital will be collected and the overall NTS and TS score will be
      measured using a validated assessment tool (Peltonen et al 2017). The association between the
      TS and NTS will be analyzed by statistical methods. In addition, after each recorded
      resuscitation situation, every member of the resuscitation team will be called by a phone.
      During the calls team members are asked to tell examples, what went well during the
      resuscitation, and what could have been done better. Based on these answers, inductive
      analysis will be made.

      A pit crew model for resuscitation will be implemented in our organizations' resuscitation
      team responding cardiac arrest alarms. We will continue to video-recording after the
      intervention, and similarly, NTS and TS will be measured using the validated assessment tool
      (Peltonen et al 2017). In the second part of the study, we will compare the pre- and
      post-intervention ALS-performance in the videos.

      Ethics

      The study protocol was approved by the Ethics Committee of Turku University. All
      ALS-situations in Turku University newer hospital building area are considered eligible to
      the study regardless of the initial rhythm or presumed aetiology. Written information consent
      of patients is not needed, because the study is directed at resuscitation team performance,
      not the patients. The patients are not identified at any phase of the study.
observational model: Case-Only
time perspective: Prospective
measure: To measure the association of the NTS and TS on one-another using validated assessment tool.
time frame: one year
measure: To evaluate the association between NTS and TS subgategories.
time frame: one year
measure: To evaluate the impact of the pit crew model.
time frame: two years
arm group label: Resuscitation team
description: Resuscitation pit crew model is educated to the resuscitation team.
intervention type: Other
intervention name: Pit crew model education
description: A pit crew model for resuscitation is educated to all resuscitation team members.
arm group label: Resuscitation team
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Miretta Tommila, MD
role: Principal Investigator
affiliation: Turku University Hospital
last name: Sanna Salanterä, PhD, RN
role: Study Director
affiliation: Vice Head of the Department of Nursing Science and Nurse Director at Turku University Hospital, Finland
last name: Ville Peltonen, Lic.Med
role: Study Chair
affiliation: Turku University Hospital
last name: Laura-Maria Peltonen, M.Sc. RN
role: Study Chair
affiliation: University of Turku, Finland, Nursing Science
last name: Teemu Elomaa, Lic.Med
role: Study Chair
affiliation: Turku University Hospital
last name: Jaana Elomaa, RN
role: Study Chair
affiliation: Turku University Hospital
last name: Tomi Pappila, RN
role: Study Chair
affiliation: Vakka-Suomi Hospital Tyks, Finland
last name: Sanna Hoppu, MD
role: Study Chair
affiliation: Tampere University Hospital, Finland
last name: Eeva Hevonoja, RN
role: Study Chair
affiliation: University of Turku, Finland
last name: Saija Hurme
role: Study Chair
affiliation: University of Turku, Finland
last name: Katariina Perkonoja
role: Study Chair
affiliation: University of Turku, Finland
citation: Nolan JP, Soar J, Zideman DA, Biarent D, Bossaert LL, Deakin C, Koster RW, Wyllie J, Bottiger B; ERC Guidelines Writing Group. European Resuscitation Council Guidelines for Resuscitation 2010 Section 1. Executive summary. Resuscitation. 2010 Oct;81(10):1219-76. doi: 10.1016/j.resuscitation.2010.08.021. No abstract available.
PMID: 20956052
citation: Fernandez Castelao E, Russo SG, Cremer S, Strack M, Kaminski L, Eich C, Timmermann A, Boos M. Positive impact of crisis resource management training on no-flow time and team member verbalisations during simulated cardiopulmonary resuscitation: a randomised controlled trial. Resuscitation. 2011 Oct;82(10):1338-43. doi: 10.1016/j.resuscitation.2011.05.009. Epub 2011 May 25.
PMID: 21664757
citation: Fletcher GC, McGeorge P, Flin RH, Glavin RJ, Maran NJ. The role of non-technical skills in anaesthesia: a review of current literature. Br J Anaesth. 2002 Mar;88(3):418-29. doi: 10.1093/bja/88.3.418. No abstract available.
PMID: 11990277
citation: Helmreich RL, Merritt AC, Wilhelm JA. The evolution of Crew Resource Management training in commercial aviation. Int J Aviat Psychol. 1999;9(1):19-32. doi: 10.1207/s15327108ijap0901_2.
PMID: 11541445
citation: Gaba DM, Howard SK, Flanagan B, Smith BE, Fish KJ, Botney R. Assessment of clinical performance during simulated crises using both technical and behavioral ratings. Anesthesiology. 1998 Jul;89(1):8-18. doi: 10.1097/00000542-199807000-00005.
PMID: 9667288
responsible party type: Sponsor
mesh term: Heart Arrest
sharing ipd: No
ipd description: Patients treated by cardiopulmonary resuscitation (CPR) in the videos can be recognized. Video material can not be shared due to patient privacy. Other data is possible to share.