<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/NCT03817892</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A02000-55</org_study_id>
    <secondary_id>17-248</secondary_id>
    <nct_id>NCT03817892</nct_id>
  </id_info>
  <brief_title>Compression Is Life In Cardiac Arrest - Human Study (CILICA-HS).</brief_title>
  <acronym>CILICA-HS</acronym>
  <official_title>Assessment of the Impact of Relay Timing and CPRmeter Guidance on the Quality of External Chest Compression: Compression Is Life In Cardiac Arrest - Human Study (CILICA-HS).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The management of out-of-hospital cardiac arrest is complex and multifactorial. With an&#xD;
      incidence between 5 and 15 per 10,000 (46,000 patients per year in France) and a survival&#xD;
      rate of only 5% to 15%, the room for improvement remains significant even today and is based&#xD;
      on fast and optimal care. Thus French and international recommendations insist on the central&#xD;
      element of external chest compression (ECC) and especially its quality (Monsieurs KG and Al.&#xD;
      Resuscitation 2015; 95: 1-80). Improving the chest compression fraction (CCF) by limiting&#xD;
      time without cardiac massage (No-Flow) is a second major point of the recommendations&#xD;
      (Vaillancourt C and Al. Resuscitation 2011; 82: 1501-7). The survival of cardiac arrest&#xD;
      victims is closely related on this No-Flow time. The principle of the chain of survival&#xD;
      (early warning - ECC - defibrillation - resuscitation) implies that the deterioration of a&#xD;
      single link threaten the whole of the care. To meet these qualitative needs, ECC guidance&#xD;
      devices have been developed. They make possible to improve the quality of the ECC achieved&#xD;
      (Hostler D and Al. BMJ 2011; 342d512). Their use is one of the areas of improvement mentioned&#xD;
      in the recommendations. Our team studied in simulation the prolonged effects of guidance on&#xD;
      the quality of the ECC during a prolonged resuscitation, with encouraging results (Buléon C&#xD;
      and Al. Am J Emerg Med 2016; 34: 1754-60). The investigators propose a study evaluating the&#xD;
      efficiency of the guidance of the ECC and the impact of the time of relay on the CCF. The&#xD;
      investigators formulate two hypotheses that they wish to test simultaneously using a 2x2&#xD;
      factorial design, in a multicenter randomized trial. The first assumption is that a 4-minute&#xD;
      relay rate improves the CCF (by reducing the No-Flow time) compared to the currently&#xD;
      recommended 2-minute relay rate. The second hypothesis is that a guiding device improves the&#xD;
      quality of the ECC.&#xD;
&#xD;
      This study should, over a period of 2 years, include 500 patients with cardiac arrest for&#xD;
      whom specialized resuscitation is undertaken. The investigators hope by this study to improve&#xD;
      the knowledge on the optimal rhythm of the ECC and to validate &quot;in vivo&quot; the interest for the&#xD;
      guidance found on manikin. This study should make it possible to clarify the recommendations&#xD;
      with a high level of evidence in this field and thus contribute to improving the prognosis of&#xD;
      the victims of an out-of-hospital cardiac arrest.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The management of out-of-hospital cardiac arrest is complex and multifactorial. With an&#xD;
      incidence between 5 and 15 per 10,000 (46,000 patients per year in France) and a survival&#xD;
      rate of only 5% to 15%, the room for improvement remains significant even today and is based&#xD;
      on fast and optimal care. Thus French and international recommendations insist on the central&#xD;
      element of external chest compression (ECC) and especially its quality (Monsieurs KG and Al.&#xD;
      Resuscitation 2015; 95: 1-80). Improving the chest compression fraction (CCF) by limiting&#xD;
      time without cardiac massage (No-Flow) is a second major point of the recommendations&#xD;
      (Vaillancourt C and Al. Resuscitation 2011; 82: 1501-7). The survival of cardiac arrest&#xD;
      victims is closely related on this No-Flow time. The principle of the chain of survival&#xD;
      (early warning - ECC - defibrillation - resuscitation) implies that the deterioration of a&#xD;
      single link threaten the whole of the care. To meet these qualitative needs, ECC guidance&#xD;
      devices have been developed. They make possible to improve the quality of the ECC achieved&#xD;
      (Hostler D and Al. BMJ 2011; 342d512). Their use is one of the areas of improvement mentioned&#xD;
      in the recommendations. Our team studied in simulation the prolonged effects of guidance on&#xD;
      the quality of the ECC during a prolonged resuscitation, with encouraging results (Buléon C&#xD;
      and Al. Am J Emerg Med 2016; 34: 1754-60). The investigators propose a study evaluating the&#xD;
      efficiency of the guidance of the ECC and the impact of the time of relay on the CCF. The&#xD;
      investigators formulate two hypotheses that they wish to test simultaneously using a 2x2&#xD;
      factorial design, in a multicenter randomized trial. The first assumption is that a 4-minute&#xD;
      relay rate improves the CCF (by reducing the No-Flow time) compared to the currently&#xD;
      recommended 2-minute relay rate. The second hypothesis is that a guiding device improves the&#xD;
      quality of the ECC.&#xD;
&#xD;
      This study should, over a period of 2 years, include 500 patients with cardiac arrest for&#xD;
      whom specialized resuscitation is undertaken. The investigators hope by this study to improve&#xD;
      the knowledge on the optimal rhythm of the ECC and to validate &quot;in vivo&quot; the interest for the&#xD;
      guidance found on manikin. This study should make it possible to clarify the recommendations&#xD;
      with a high level of evidence in this field and thus contribute to improving the prognosis of&#xD;
      the victims of an out-of-hospital cardiac arrest.&#xD;
&#xD;
      Cardiac arrest (CA) remains a challenge for pre-hospital care. With an incidence of between 5&#xD;
      and 15 per 10,000 (46,000 patients per year in France) and a survival rate of only 5% to 15%,&#xD;
      there is yet room for improvement in treatment to reduce morbi-mortality of these patients.&#xD;
      The quality of cardiopulmonary resuscitation (CPR) is at the heart of the last three&#xD;
      five-year recommendations. (1-3) The latest recommendations emphasize the importance for&#xD;
      professionals to work at the highest quality of CPR and External Chest Compression (ECC)&#xD;
      possible. (3) The ratio of the time during which the ECC is performed (Low-Flow) to the total&#xD;
      time of the resuscitation is referred to as the Chest Compression Fraction (CCF). During CPR,&#xD;
      it is essential for the patient's survival to minimize ECC disruption times and therefore to&#xD;
      increase the CCF, as this is an independent element in CA survival's improvement. (4,5) ECC&#xD;
      interruptions are deleterious to at least two titles. First, they are a source of direct stop&#xD;
      in cerebral and coronary perfusions potentially altering the neurological prognosis and the&#xD;
      probability of Return of Spontaneous Circulation. (6) Secondly, the quality of the cardiac&#xD;
      output generated by the ECC at the time of resuming of the ECC after an interruption is less&#xD;
      good for more than 30 seconds: time need for that several chest compressions can restore the&#xD;
      best flow possible. (6,7) Reducing these interruptions and improving the ECC is therefore a&#xD;
      major goal of improving CPR. The guidelines are that CCF must be greater than 60% and some&#xD;
      experts estimate that a CCF of 80% is possible. (8,9) The outcome of patients with&#xD;
      pre-hospital CA is significantly, positively and independently correlated with the&#xD;
      consistency to different CCF targets, ECC frequency, ECC depth, and brief pre-external&#xD;
      electric shock pause (&lt;10 seconds). (10) There is evidence that ECC's guidance improves&#xD;
      adequacy to guidelines and allows to be closer with the ECC frequency, depth and release&#xD;
      objectives. (11) The investigators have proved in simulation that the guidance of the ECC&#xD;
      delays the deterioration of the overall quality of the ECC and its components (frequency,&#xD;
      depth and relaxation) related to fatigue during a prolonged ECC beyond the 2 ECC relay&#xD;
      minutes currently recommended. (12) Strategies to get closer with the guidelines regarding&#xD;
      the quality of the ECC associated with an improvement in CCF should add or even enhance their&#xD;
      beneficial effects for the management of CA victims. Achieving high quality CPR requires the&#xD;
      measurement of quality of CPR (ECC and CCF). (13,14) This idea of a support strategy enhanced&#xD;
      by &quot;bundles&quot; of concepts is developing in the literature. Thus Cheskes S et al. Describe a&#xD;
      &quot;high quality CPR&quot; such as the association of a CCF greater than 70% and achievement of the&#xD;
      objectives of the recommendations for the frequency and depth of the ECC. (15) The place of&#xD;
      devices for guiding the quality of the ECC needs to be specified. Indeed, studies of their&#xD;
      use in real-life situations are criticized for their methodological qualities and their size.&#xD;
      (16) The use of a real-time guidance device is proposed as a possibility in the latest&#xD;
      guidelines without being an indispensable element due to the lack of current evidence. (3)&#xD;
      Its use or non-use does not imply any obvious loss of chance for patients. Evidence as to its&#xD;
      usefulness therefore remains to be sought.&#xD;
&#xD;
      For this reason, the investigators wish, through an original, randomized, multi-center study,&#xD;
      to provide some answers to the questions about the possibility of an improvement in CCF by&#xD;
      the lengthening of the time between two ECC relays and the effect of guidance on the quality&#xD;
      of the ECC. The design of the study will also allow to approach a possible combined effect of&#xD;
      ECC relays rhythm and guidance. The currently recommended duration of a two-minute ECC cycle&#xD;
      between two relays does not have a consistent evidence based and corresponds to a duration&#xD;
      for which the ECC effort can be maintained in principle with efficiency. (3) Objective&#xD;
      measures have shown that the quality of the ECC can be maintained beyond 2 minutes. Extending&#xD;
      the duration of an ECC cycle could reduce the number of ECC interruptions and thus improve&#xD;
      the CCF.&#xD;
&#xD;
      The investigators therefore formulate two hypotheses that they wish to test simultaneously&#xD;
      using a 2x2 factorial design, in a multicenter randomized trial. The first assumption is that&#xD;
      a 4-minutes relay rhythm improves the CCF (by reducing the No-Flow time) compared to the&#xD;
      currently recommended 2-minutes relay rhythm. The second hypothesis is that a guiding device&#xD;
      improves the quality of the ECC.&#xD;
&#xD;
      The CPRmeter® (guidance device used in this study) will record data on the ECC and its&#xD;
      quality (depth, frequency, relaxation, CPRmeter® use time, No-Flow time and Low-Flow time) as&#xD;
      well as ECC guidance for the group which will benefit from it (the other group will have the&#xD;
      screen masked by a screen cap).&#xD;
&#xD;
      This study should, over a period of 2 years, include 500 major patients presenting a&#xD;
      non-traumatic CA for whom a specialized CPR is undertaken. The investigators hope by this&#xD;
      study to improve the knowledge on the optimal rhythm of the CEE and to validate &quot;in vivo&quot; the&#xD;
      interest for the guidance found on manikin. This study should clarify the guidelines with a&#xD;
      high level of evidence in this area and thus contribute to improving the prognosis of victims&#xD;
      of out-hospital CA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2024</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>Factorial Assignment</intervention_model>
    <intervention_model_description>This is a randomized, multicenter, open-label study using a 2x2 factorial design comparing (i) the rhythm of External Chest Compression relays every 4 minutes versus every 2 minutes on the Chest Compression Fraction; (ii) the use of real-time guidance of the External Chest Compression via a feedback device (CPRmeter®) versus no guidance on the quality of the External Chest Compression (correct compression score).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The participants being in cardiac arrest at the time of the performance of the study, they are not aware of the arm of randomization in which they are initialy and they are inform as soon as their clinical status allow it.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Chest Compression Fraction</measure>
    <time_frame>1 day</time_frame>
    <description>The Chest Compression Fraction (in percentage) corresponds to the resuscitation time during which a External Chest Compression is performed (Low Flow) related to the patient's management time by the prehospital rescue team.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correct Compression Score</measure>
    <time_frame>1 day</time_frame>
    <description>The correct compression score (in percentage) corresponds to a External Chest Compression for which simultaneously the depth is correct (50 to 60 mm), the frequency is correct (100 to 120 / min) and the relaxation is correct (&lt;2500 g) .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depth of External Chest Compression</measure>
    <time_frame>1 day</time_frame>
    <description>The depth of External Chest Compression (in millimeters) continuously recorded by the guidance system (average and percentage correct).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of External Chest Compression</measure>
    <time_frame>1 day</time_frame>
    <description>The frequency of External Chest Compression (in number of compression per minute) recorded continuously by the guidance system (average and percentage correct)....</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relaxation of External Chest Compression</measure>
    <time_frame>1 day</time_frame>
    <description>The relaxation of External Chest Compression corresponds to the residual force (in grams) recorded continuously by the guidance system (average and percentage correct)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective rescuers' fatigue</measure>
    <time_frame>1 day</time_frame>
    <description>The subjective fatigue assessed by rescuers who performed External Chest Compression using the Borg scale (average of the Borg Scale values of rescuers)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The delays and durations of care</measure>
    <time_frame>1 day</time_frame>
    <description>The delays and durations of care (in minutes and seconds) based on the following events: cardiac arrest time, start time of the External Chest Compression, start time of resuscitation by the prehospital rescue team, end time of resuscitation (ROSC or death of the patient).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>No-Flow and Low-Flow times</measure>
    <time_frame>1 day</time_frame>
    <description>The times (in minutes and seconds) of No-Flow (time during which no External Chest Compression is performed) and Low-Flow (time during which External Chest Compression is performed, generating a minimum flow rate of organs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recuperation of Spontaneous Circulation</measure>
    <time_frame>1 day</time_frame>
    <description>The rate of Recuperation of Spontaneous Circulation (percentage).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>survival at hospital arrival</measure>
    <time_frame>1 day</time_frame>
    <description>The rate of survival at hospital arrival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuron Specific Enolase</measure>
    <time_frame>Day 1 and day 3</time_frame>
    <description>The serum Neuron Specific Enolase level (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>Day 2 and one month.</time_frame>
    <description>The survival rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral Performance Category Score</measure>
    <time_frame>up to one month.</time_frame>
    <description>Cerebral Performance Category Score as discribe in Wijdicks EFM et al. Neurology 2006;67:203-10.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Demographic data</measure>
    <time_frame>Day 1</time_frame>
    <description>Demographic data of the population (sexe, age, suspect cause of cardiac arrest, etc)</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cardiac Arrest</condition>
  <condition>Cardiopulmonary Resuscitation</condition>
  <arm_group>
    <arm_group_label>Unguided 2 minutes (U2)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The External Chest Compression are performed without guidance of the CPRmeter device (according to the current guidelines).&#xD;
The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 2 minutes according to the current guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unguided 4 minutes (U4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The External Chest Compression are performed without guidance of the CPRmeter device (according to the current guidelines).&#xD;
The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 4 minutes. (Rhythm of a relay 4 minutes)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guided 2 minutes (G2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The External Chest Compression are performed with guidance of the CPRmeter device. (Guidance of the External Chest Compression) The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 2 minutes according to the current guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guided 4 minutes (G4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The External Chest Compression are performed with guidance of the CPRmeter device. (Guidance of the External Chest Compression) The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 4 minutes. (Rhythm of a relay 4 minutes)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Guidance of the External Chest Compression</intervention_name>
    <description>The CPRmeter® device is positioned on the patient's chest with a disposable adhesive. In the situation of guidance of the External Chest Compression the rescuers have access in real time on the screen to visual feedback on the quality of the External Chest Compression performed and indications of possible corrections to improve the quality of the External Chest Compression . In the case of non-guidance of the External Chest Compression , a mask is position on the screen in order to hide the feedback information.</description>
    <arm_group_label>Guided 2 minutes (G2)</arm_group_label>
    <arm_group_label>Guided 4 minutes (G4)</arm_group_label>
    <other_name>CPRmeter's feedback</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rhythm of a relay 4 minutes</intervention_name>
    <description>The duration or rhythm of a relay is the time during which a rescuer performs External Chest Compression before being relayed by another rescuer. This time is 2 minutes in non intervention group according to the current guidelines and 4 minutes in experimental group.</description>
    <arm_group_label>Guided 4 minutes (G4)</arm_group_label>
    <arm_group_label>Unguided 4 minutes (U4)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major person&#xD;
&#xD;
          -  Victim of a cardiorespiratory arrest&#xD;
&#xD;
          -  Eligible for inclusion procedure in immediate life emergency&#xD;
&#xD;
          -  Affiliated to the social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor person.&#xD;
&#xD;
          -  Pregnant woman over 6 months old or breastfeeding.&#xD;
&#xD;
          -  Known incurable disease.&#xD;
&#xD;
          -  Palliative care in progress.&#xD;
&#xD;
          -  Decision not to resuscitate from the patient (anticipated directives) or from the&#xD;
             medical team.&#xD;
&#xD;
          -  Traumatic cardiac arrest.&#xD;
&#xD;
          -  Impossibility or contraindication to the use of the External Chest Compression&#xD;
             guidance system.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clément BULEON, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Caen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre-Yves GUEUGNIAUD, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital of Lyon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric ROUPIE, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital of Caen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Clément BULEON, MD</last_name>
    <phone>+33(0)231064736</phone>
    <email>buleon-c@chu-caen.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laurent HALBOUT, MD</last_name>
    <phone>+33(0)231063400</phone>
    <email>halbout-l@chu-caen.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital of Caen</name>
      <address>
        <city>Caen</city>
        <state>Normandy</state>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clement BULEON, MD</last_name>
      <phone>+(33)231064736</phone>
      <email>buleon-c@chu-caen.fr</email>
    </contact>
    <investigator>
      <last_name>Laurent HALBOUT, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xavier ARROT, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80080</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christophe BOYER, MD</last_name>
      <email>boyer.christophe@chu-amiens.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital of Cherbourg - Louis Pasteur</name>
      <address>
        <city>Cherbourg</city>
        <zip>50100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Catalin MUNTEAN, MD</last_name>
      <email>c.muntean@ch-cotentin.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital of Elbeuf Louviers Val de Reuil</name>
      <address>
        <city>Elbeuf</city>
        <zip>76503</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmanuel MOREL-MARECHAL, MD</last_name>
      <email>emmanuel.morelmarechal@chi-elbeuf-louviers.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital of Le Havre -</name>
      <address>
        <city>Le Havre</city>
        <zip>76290</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xavier BENET, MD</last_name>
      <email>xav.benet@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital of Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kevin HUSSON, MD</last_name>
      <email>husson.k@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital of Lisieux - Robert Bisson</name>
      <address>
        <city>Lisieux</city>
        <zip>14100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Antoine AUBRION, MD</last_name>
      <email>aubrion.antoine@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital of Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Eric CESAREO, MD</last_name>
      <email>eric.cesareo@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital of Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Benoit JARDEL, MD</last_name>
      <email>benoit.jardel@chu-rouen.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital of Valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <zip>59300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Carine VANDERSTRAETEN, MD</last_name>
      <email>vanderstraeten-c@ch-valenciennes.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Eure-Seine Evreux</name>
      <address>
        <city>Évreux</city>
        <zip>27015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Florian ANDRIRAMIRADO, MD</last_name>
      <email>florian.andriamirado@chi-eureseine.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>International Liaison Committee on Resuscitation. 2005 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Part 4: Advanced life support. Resuscitation. 2005 Nov-Dec;67(2-3):213-47. doi: 10.1016/j.resuscitation.2005.09.018. No abstract available.</citation>
    <PMID>16324990</PMID>
  </reference>
  <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>Monsieurs KG, Nolan JP, Bossaert LL, Greif R, Maconochie IK, Nikolaou NI, Perkins GD, Soar J, Truhlar A, Wyllie J, Zideman DA; ERC Guidelines 2015 Writing Group. European Resuscitation Council Guidelines for Resuscitation 2015: Section 1. Executive summary. Resuscitation. 2015 Oct;95:1-80. doi: 10.1016/j.resuscitation.2015.07.038. Epub 2015 Oct 15. No abstract available.</citation>
    <PMID>26477410</PMID>
  </reference>
  <reference>
    <citation>Christenson J, Andrusiek D, Everson-Stewart S, Kudenchuk P, Hostler D, Powell J, Callaway CW, Bishop D, Vaillancourt C, Davis D, Aufderheide TP, Idris A, Stouffer JA, Stiell I, Berg R; Resuscitation Outcomes Consortium Investigators. Chest compression fraction determines survival in patients with out-of-hospital ventricular fibrillation. Circulation. 2009 Sep 29;120(13):1241-7. doi: 10.1161/CIRCULATIONAHA.109.852202. Epub 2009 Sep 14.</citation>
    <PMID>19752324</PMID>
  </reference>
  <reference>
    <citation>Wik L, Olsen JA, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, Travis DT, Herken UR, Lerner EB. Why do some studies find that CPR fraction is not a predictor of survival? Resuscitation. 2016 Jul;104:59-62. doi: 10.1016/j.resuscitation.2016.04.013. Epub 2016 May 4.</citation>
    <PMID>27155547</PMID>
  </reference>
  <reference>
    <citation>Berg RA, Sanders AB, Kern KB, Hilwig RW, Heidenreich JW, Porter ME, Ewy GA. Adverse hemodynamic effects of interrupting chest compressions for rescue breathing during cardiopulmonary resuscitation for ventricular fibrillation cardiac arrest. Circulation. 2001 Nov 13;104(20):2465-70. doi: 10.1161/hc4501.098926.</citation>
    <PMID>11705826</PMID>
  </reference>
  <reference>
    <citation>Cunningham LM, Mattu A, O'Connor RE, Brady WJ. Cardiopulmonary resuscitation for cardiac arrest: the importance of uninterrupted chest compressions in cardiac arrest resuscitation. Am J Emerg Med. 2012 Oct;30(8):1630-8. doi: 10.1016/j.ajem.2012.02.015. Epub 2012 May 23.</citation>
    <PMID>22633716</PMID>
  </reference>
  <reference>
    <citation>Kleinman ME, Brennan EE, Goldberger ZD, Swor RA, Terry M, Bobrow BJ, Gazmuri RJ, Travers AH, Rea T. Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S414-35. doi: 10.1161/CIR.0000000000000259. No abstract available.</citation>
    <PMID>26472993</PMID>
  </reference>
  <reference>
    <citation>Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, Bossaert LL, Brett SJ, Chamberlain D, de Caen AR, Deakin CD, Finn JC, Grasner JT, Hazinski MF, Iwami T, Koster RW, Lim SH, Ma MH, McNally BF, Morley PT, Morrison LJ, Monsieurs KG, Montgomery W, Nichol G, Okada K, Ong ME, Travers AH, Nolan JP; Utstein Collaborators. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: A Statement for Healthcare Professionals From a Task Force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Resuscitation. 2015 Nov;96:328-40. doi: 10.1016/j.resuscitation.2014.11.002. Epub 2014 Nov 11.</citation>
    <PMID>25438254</PMID>
  </reference>
  <reference>
    <citation>Cheskes S, Schmicker RH, Rea T, Morrison LJ, Grunau B, Drennan IR, Leroux B, Vaillancourt C, Schmidt TA, Koller AC, Kudenchuk P, Aufderheide TP, Herren H, Flickinger KH, Charleston M, Straight R, Christenson J; ROC investigators. The association between AHA CPR quality guideline compliance and clinical outcomes from out-of-hospital cardiac arrest. Resuscitation. 2017 Jul;116:39-45. doi: 10.1016/j.resuscitation.2017.05.003. Epub 2017 May 2.</citation>
    <PMID>28476474</PMID>
  </reference>
  <reference>
    <citation>Hostler D, Everson-Stewart S, Rea TD, Stiell IG, Callaway CW, Kudenchuk PJ, Sears GK, Emerson SS, Nichol G; Resuscitation Outcomes Consortium Investigators. Effect of real-time feedback during cardiopulmonary resuscitation outside hospital: prospective, cluster-randomised trial. BMJ. 2011 Feb 4;342:d512. doi: 10.1136/bmj.d512.</citation>
    <PMID>21296838</PMID>
  </reference>
  <reference>
    <citation>Buleon C, Delaunay J, Parienti JJ, Halbout L, Arrot X, Gerard JL, Hanouz JL. Impact of a feedback device on chest compression quality during extended manikin CPR: a randomized crossover study. Am J Emerg Med. 2016 Sep;34(9):1754-60. doi: 10.1016/j.ajem.2016.05.077. Epub 2016 May 28.</citation>
    <PMID>27349359</PMID>
  </reference>
  <reference>
    <citation>Goodloe JM, Idris AH. Metrics save lives: value and hurdles faced. Curr Opin Crit Care. 2017 Jun;23(3):204-208. doi: 10.1097/MCC.0000000000000408.</citation>
    <PMID>28379867</PMID>
  </reference>
  <reference>
    <citation>Lin S, Scales DC. Cardiopulmonary resuscitation quality and beyond: the need to improve real-time feedback and physiologic monitoring. Crit Care. 2016 Jun 28;20(1):182. doi: 10.1186/s13054-016-1371-9.</citation>
    <PMID>27349642</PMID>
  </reference>
  <reference>
    <citation>Cheskes S, Byers A, Zhan C, Verbeek PR, Ko D, Drennan IR, Buick JE, Brooks SC, Lin S, Taher A, Morrison LJ; Rescu Epistry Investigators. CPR quality during out-of-hospital cardiac arrest transport. Resuscitation. 2017 May;114:34-39. doi: 10.1016/j.resuscitation.2017.02.016. Epub 2017 Feb 24.</citation>
    <PMID>28242210</PMID>
  </reference>
  <reference>
    <citation>Wallace SK, Abella BS, Becker LB. Quantifying the effect of cardiopulmonary resuscitation quality on cardiac arrest outcome: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):148-56. doi: 10.1161/CIRCOUTCOMES.111.000041. Epub 2013 Mar 12.</citation>
    <PMID>23481533</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>No-Flow</keyword>
  <keyword>Chest Compression Fraction</keyword>
  <keyword>Out Hospital</keyword>
  <keyword>External Chest Compression Relay</keyword>
  <keyword>External Chest Compression Guidance</keyword>
  <keyword>External Chest Compression Quality</keyword>
  <keyword>Correct Compression Score</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/NCT03817892
org study id: 2018-A02000-55
secondary id: 17-248
nct id: NCT03817892
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The management of out-of-hospital cardiac arrest is complex and multifactorial. With an
      incidence between 5 and 15 per 10,000 (46,000 patients per year in France) and a survival
      rate of only 5% to 15%, the room for improvement remains significant even today and is based
      on fast and optimal care. Thus French and international recommendations insist on the central
      element of external chest compression (ECC) and especially its quality (Monsieurs KG and Al.
      Resuscitation 2015; 95: 1-80). Improving the chest compression fraction (CCF) by limiting
      time without cardiac massage (No-Flow) is a second major point of the recommendations
      (Vaillancourt C and Al. Resuscitation 2011; 82: 1501-7). The survival of cardiac arrest
      victims is closely related on this No-Flow time. The principle of the chain of survival
      (early warning - ECC - defibrillation - resuscitation) implies that the deterioration of a
      single link threaten the whole of the care. To meet these qualitative needs, ECC guidance
      devices have been developed. They make possible to improve the quality of the ECC achieved
      (Hostler D and Al. BMJ 2011; 342d512). Their use is one of the areas of improvement mentioned
      in the recommendations. Our team studied in simulation the prolonged effects of guidance on
      the quality of the ECC during a prolonged resuscitation, with encouraging results (Buléon C
      and Al. Am J Emerg Med 2016; 34: 1754-60). The investigators propose a study evaluating the
      efficiency of the guidance of the ECC and the impact of the time of relay on the CCF. The
      investigators formulate two hypotheses that they wish to test simultaneously using a 2x2
      factorial design, in a multicenter randomized trial. The first assumption is that a 4-minute
      relay rate improves the CCF (by reducing the No-Flow time) compared to the currently
      recommended 2-minute relay rate. The second hypothesis is that a guiding device improves the
      quality of the ECC.

      This study should, over a period of 2 years, include 500 patients with cardiac arrest for
      whom specialized resuscitation is undertaken. The investigators hope by this study to improve
      the knowledge on the optimal rhythm of the ECC and to validate "in vivo" the interest for the
      guidance found on manikin. This study should make it possible to clarify the recommendations
      with a high level of evidence in this field and thus contribute to improving the prognosis of
      the victims of an out-of-hospital cardiac arrest.
The management of out-of-hospital cardiac arrest is complex and multifactorial. With an
      incidence between 5 and 15 per 10,000 (46,000 patients per year in France) and a survival
      rate of only 5% to 15%, the room for improvement remains significant even today and is based
      on fast and optimal care. Thus French and international recommendations insist on the central
      element of external chest compression (ECC) and especially its quality (Monsieurs KG and Al.
      Resuscitation 2015; 95: 1-80). Improving the chest compression fraction (CCF) by limiting
      time without cardiac massage (No-Flow) is a second major point of the recommendations
      (Vaillancourt C and Al. Resuscitation 2011; 82: 1501-7). The survival of cardiac arrest
      victims is closely related on this No-Flow time. The principle of the chain of survival
      (early warning - ECC - defibrillation - resuscitation) implies that the deterioration of a
      single link threaten the whole of the care. To meet these qualitative needs, ECC guidance
      devices have been developed. They make possible to improve the quality of the ECC achieved
      (Hostler D and Al. BMJ 2011; 342d512). Their use is one of the areas of improvement mentioned
      in the recommendations. Our team studied in simulation the prolonged effects of guidance on
      the quality of the ECC during a prolonged resuscitation, with encouraging results (Buléon C
      and Al. Am J Emerg Med 2016; 34: 1754-60). The investigators propose a study evaluating the
      efficiency of the guidance of the ECC and the impact of the time of relay on the CCF. The
      investigators formulate two hypotheses that they wish to test simultaneously using a 2x2
      factorial design, in a multicenter randomized trial. The first assumption is that a 4-minute
      relay rate improves the CCF (by reducing the No-Flow time) compared to the currently
      recommended 2-minute relay rate. The second hypothesis is that a guiding device improves the
      quality of the ECC.

      This study should, over a period of 2 years, include 500 patients with cardiac arrest for
      whom specialized resuscitation is undertaken. The investigators hope by this study to improve
      the knowledge on the optimal rhythm of the ECC and to validate "in vivo" the interest for the
      guidance found on manikin. This study should make it possible to clarify the recommendations
      with a high level of evidence in this field and thus contribute to improving the prognosis of
      the victims of an out-of-hospital cardiac arrest.

      Cardiac arrest (CA) remains a challenge for pre-hospital care. With an incidence of between 5
      and 15 per 10,000 (46,000 patients per year in France) and a survival rate of only 5% to 15%,
      there is yet room for improvement in treatment to reduce morbi-mortality of these patients.
      The quality of cardiopulmonary resuscitation (CPR) is at the heart of the last three
      five-year recommendations. (1-3) The latest recommendations emphasize the importance for
      professionals to work at the highest quality of CPR and External Chest Compression (ECC)
      possible. (3) The ratio of the time during which the ECC is performed (Low-Flow) to the total
      time of the resuscitation is referred to as the Chest Compression Fraction (CCF). During CPR,
      it is essential for the patient's survival to minimize ECC disruption times and therefore to
      increase the CCF, as this is an independent element in CA survival's improvement. (4,5) ECC
      interruptions are deleterious to at least two titles. First, they are a source of direct stop
      in cerebral and coronary perfusions potentially altering the neurological prognosis and the
      probability of Return of Spontaneous Circulation. (6) Secondly, the quality of the cardiac
      output generated by the ECC at the time of resuming of the ECC after an interruption is less
      good for more than 30 seconds: time need for that several chest compressions can restore the
      best flow possible. (6,7) Reducing these interruptions and improving the ECC is therefore a
      major goal of improving CPR. The guidelines are that CCF must be greater than 60% and some
      experts estimate that a CCF of 80% is possible. (8,9) The outcome of patients with
      pre-hospital CA is significantly, positively and independently correlated with the
      consistency to different CCF targets, ECC frequency, ECC depth, and brief pre-external
      electric shock pause (<10 seconds). (10) There is evidence that ECC's guidance improves
      adequacy to guidelines and allows to be closer with the ECC frequency, depth and release
      objectives. (11) The investigators have proved in simulation that the guidance of the ECC
      delays the deterioration of the overall quality of the ECC and its components (frequency,
      depth and relaxation) related to fatigue during a prolonged ECC beyond the 2 ECC relay
      minutes currently recommended. (12) Strategies to get closer with the guidelines regarding
      the quality of the ECC associated with an improvement in CCF should add or even enhance their
      beneficial effects for the management of CA victims. Achieving high quality CPR requires the
      measurement of quality of CPR (ECC and CCF). (13,14) This idea of a support strategy enhanced
      by "bundles" of concepts is developing in the literature. Thus Cheskes S et al. Describe a
      "high quality CPR" such as the association of a CCF greater than 70% and achievement of the
      objectives of the recommendations for the frequency and depth of the ECC. (15) The place of
      devices for guiding the quality of the ECC needs to be specified. Indeed, studies of their
      use in real-life situations are criticized for their methodological qualities and their size.
      (16) The use of a real-time guidance device is proposed as a possibility in the latest
      guidelines without being an indispensable element due to the lack of current evidence. (3)
      Its use or non-use does not imply any obvious loss of chance for patients. Evidence as to its
      usefulness therefore remains to be sought.

      For this reason, the investigators wish, through an original, randomized, multi-center study,
      to provide some answers to the questions about the possibility of an improvement in CCF by
      the lengthening of the time between two ECC relays and the effect of guidance on the quality
      of the ECC. The design of the study will also allow to approach a possible combined effect of
      ECC relays rhythm and guidance. The currently recommended duration of a two-minute ECC cycle
      between two relays does not have a consistent evidence based and corresponds to a duration
      for which the ECC effort can be maintained in principle with efficiency. (3) Objective
      measures have shown that the quality of the ECC can be maintained beyond 2 minutes. Extending
      the duration of an ECC cycle could reduce the number of ECC interruptions and thus improve
      the CCF.

      The investigators therefore formulate two hypotheses that they wish to test simultaneously
      using a 2x2 factorial design, in a multicenter randomized trial. The first assumption is that
      a 4-minutes relay rhythm improves the CCF (by reducing the No-Flow time) compared to the
      currently recommended 2-minutes relay rhythm. The second hypothesis is that a guiding device
      improves the quality of the ECC.

      The CPRmeter® (guidance device used in this study) will record data on the ECC and its
      quality (depth, frequency, relaxation, CPRmeter® use time, No-Flow time and Low-Flow time) as
      well as ECC guidance for the group which will benefit from it (the other group will have the
      screen masked by a screen cap).

      This study should, over a period of 2 years, include 500 major patients presenting a
      non-traumatic CA for whom a specialized CPR is undertaken. The investigators hope by this
      study to improve the knowledge on the optimal rhythm of the CEE and to validate "in vivo" the
      interest for the guidance found on manikin. This study should clarify the guidelines with a
      high level of evidence in this area and thus contribute to improving the prognosis of victims
      of out-hospital CA.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: This is a randomized, multicenter, open-label study using a 2x2 factorial design comparing (i) the rhythm of External Chest Compression relays every 4 minutes versus every 2 minutes on the Chest Compression Fraction; (ii) the use of real-time guidance of the External Chest Compression via a feedback device (CPRmeter®) versus no guidance on the quality of the External Chest Compression (correct compression score).
primary purpose: Other
masking: None (Open Label)
masking description: The participants being in cardiac arrest at the time of the performance of the study, they are not aware of the arm of randomization in which they are initialy and they are inform as soon as their clinical status allow it.
measure: Chest Compression Fraction
time frame: 1 day
description: The Chest Compression Fraction (in percentage) corresponds to the resuscitation time during which a External Chest Compression is performed (Low Flow) related to the patient's management time by the prehospital rescue team.
measure: Correct Compression Score
time frame: 1 day
description: The correct compression score (in percentage) corresponds to a External Chest Compression for which simultaneously the depth is correct (50 to 60 mm), the frequency is correct (100 to 120 / min) and the relaxation is correct (<2500 g) .
measure: Depth of External Chest Compression
time frame: 1 day
description: The depth of External Chest Compression (in millimeters) continuously recorded by the guidance system (average and percentage correct).
measure: Frequency of External Chest Compression
time frame: 1 day
description: The frequency of External Chest Compression (in number of compression per minute) recorded continuously by the guidance system (average and percentage correct)....
measure: Relaxation of External Chest Compression
time frame: 1 day
description: The relaxation of External Chest Compression corresponds to the residual force (in grams) recorded continuously by the guidance system (average and percentage correct)
measure: Subjective rescuers' fatigue
time frame: 1 day
description: The subjective fatigue assessed by rescuers who performed External Chest Compression using the Borg scale (average of the Borg Scale values of rescuers)
measure: The delays and durations of care
time frame: 1 day
description: The delays and durations of care (in minutes and seconds) based on the following events: cardiac arrest time, start time of the External Chest Compression, start time of resuscitation by the prehospital rescue team, end time of resuscitation (ROSC or death of the patient).
measure: No-Flow and Low-Flow times
time frame: 1 day
description: The times (in minutes and seconds) of No-Flow (time during which no External Chest Compression is performed) and Low-Flow (time during which External Chest Compression is performed, generating a minimum flow rate of organs).
measure: Recuperation of Spontaneous Circulation
time frame: 1 day
description: The rate of Recuperation of Spontaneous Circulation (percentage).
measure: survival at hospital arrival
time frame: 1 day
description: The rate of survival at hospital arrival
measure: Neuron Specific Enolase
time frame: Day 1 and day 3
description: The serum Neuron Specific Enolase level (ng/mL)
measure: Survival
time frame: Day 2 and one month.
description: The survival rate.
measure: Cerebral Performance Category Score
time frame: up to one month.
description: Cerebral Performance Category Score as discribe in Wijdicks EFM et al. Neurology 2006;67:203-10.
measure: Demographic data
time frame: Day 1
description: Demographic data of the population (sexe, age, suspect cause of cardiac arrest, etc)
arm group label: Unguided 2 minutes (U2)
arm group type: No Intervention
description: The External Chest Compression are performed without guidance of the CPRmeter device (according to the current guidelines).
The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 2 minutes according to the current guidelines.
arm group label: Unguided 4 minutes (U4)
arm group type: Experimental
description: The External Chest Compression are performed without guidance of the CPRmeter device (according to the current guidelines).
The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 4 minutes. (Rhythm of a relay 4 minutes)
arm group label: Guided 2 minutes (G2)
arm group type: Experimental
description: The External Chest Compression are performed with guidance of the CPRmeter device. (Guidance of the External Chest Compression) The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 2 minutes according to the current guidelines.
arm group label: Guided 4 minutes (G4)
arm group type: Experimental
description: The External Chest Compression are performed with guidance of the CPRmeter device. (Guidance of the External Chest Compression) The duration or rhythm of a relay during which a rescuer performs External Chest Compression before being relayed by another rescuer is 4 minutes. (Rhythm of a relay 4 minutes)
intervention type: Other
intervention name: Guidance of the External Chest Compression
description: The CPRmeter® device is positioned on the patient's chest with a disposable adhesive. In the situation of guidance of the External Chest Compression the rescuers have access in real time on the screen to visual feedback on the quality of the External Chest Compression performed and indications of possible corrections to improve the quality of the External Chest Compression . In the case of non-guidance of the External Chest Compression , a mask is position on the screen in order to hide the feedback information.
arm group label: Guided 2 minutes (G2)
arm group label: Guided 4 minutes (G4)
other name: CPRmeter's feedback
intervention type: Other
intervention name: Rhythm of a relay 4 minutes
description: The duration or rhythm of a relay is the time during which a rescuer performs External Chest Compression before being relayed by another rescuer. This time is 2 minutes in non intervention group according to the current guidelines and 4 minutes in experimental group.
arm group label: Guided 4 minutes (G4)
arm group label: Unguided 4 minutes (U4)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clément BULEON, MD
role: Principal Investigator
affiliation: University Hospital of Caen
last name: Pierre-Yves GUEUGNIAUD, MD, PhD
role: Study Chair
affiliation: University Hospital of Lyon
last name: Eric ROUPIE, MD, PhD
role: Study Chair
affiliation: University Hospital of Caen
last name: Clément BULEON, MD
phone: +33(0)231064736
email: buleon-c@chu-caen.fr
last name: Laurent HALBOUT, MD
phone: +33(0)231063400
email: halbout-l@chu-caen.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
citation: International Liaison Committee on Resuscitation. 2005 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Part 4: Advanced life support. Resuscitation. 2005 Nov-Dec;67(2-3):213-47. doi: 10.1016/j.resuscitation.2005.09.018. No abstract available.
PMID: 16324990
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: Monsieurs KG, Nolan JP, Bossaert LL, Greif R, Maconochie IK, Nikolaou NI, Perkins GD, Soar J, Truhlar A, Wyllie J, Zideman DA; ERC Guidelines 2015 Writing Group. European Resuscitation Council Guidelines for Resuscitation 2015: Section 1. Executive summary. Resuscitation. 2015 Oct;95:1-80. doi: 10.1016/j.resuscitation.2015.07.038. Epub 2015 Oct 15. No abstract available.
PMID: 26477410
citation: Christenson J, Andrusiek D, Everson-Stewart S, Kudenchuk P, Hostler D, Powell J, Callaway CW, Bishop D, Vaillancourt C, Davis D, Aufderheide TP, Idris A, Stouffer JA, Stiell I, Berg R; Resuscitation Outcomes Consortium Investigators. Chest compression fraction determines survival in patients with out-of-hospital ventricular fibrillation. Circulation. 2009 Sep 29;120(13):1241-7. doi: 10.1161/CIRCULATIONAHA.109.852202. Epub 2009 Sep 14.
PMID: 19752324
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responsible party type: Sponsor
mesh term: Heart Arrest
sharing ipd: Undecided