<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/NCT03021122</url>
  </required_header>
  <id_info>
    <org_study_id>SNSF_32003B_169348</org_study_id>
    <nct_id>NCT03021122</nct_id>
  </id_info>
  <brief_title>Reducing Medication Errors and Time to Drugs Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter RCT</brief_title>
  <official_title>Reducing Medication Errors and Time to Vasoactive Drugs Preparation and Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pediatric Clinical Research Platform</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Geneva, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Neuchâtel Hospital, Neuchâtel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fribourg Hospital, Fribourg, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sion Hospital, Sion, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pediatric Clinical Research Platform</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>
      The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or&#xD;
      divisions to prepare continuous infusions of vasoactive drugs during a simulation-based&#xD;
      pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to&#xD;
      prepare and deliver vasoactive drugs following their current conventional methods or by the&#xD;
      aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them&#xD;
      step-by-step from order to delivery of these drugs.&#xD;
&#xD;
        1. Primary outcome will be to measure in each allocation group the number of medication&#xD;
           dosage errors committed during each drug preparation sequence until injection.&#xD;
&#xD;
        2. Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug&#xD;
           delivery (TDD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for&#xD;
      continuous infusion is both complex and time-consuming, placing children at higher risk than&#xD;
      adults for medication errors. It is well established that CPR duration is inversely&#xD;
      correlated to survival, decreasing linearly by 2.1 % per minute, and to decreased risk of&#xD;
      neurological sequelae [1].&#xD;
&#xD;
      In this study, the investigators recruit nurses working in 5 swiss Pediatric Emergency&#xD;
      Departments or divisions to prepare continuous infusions of vasoactive drugs during a&#xD;
      simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin (Laerdal&#xD;
      SimJunior™). The scenario will take place in the shock room to increase realism.&#xD;
&#xD;
      According to randomization with a 1:1 allocation ratio, nurses will have to prepare and&#xD;
      deliver vasoactive drugs following their current conventional methods or by the aim of a&#xD;
      mobile tablet application called PedAMINES™ (Pediatric Accurate Medication In Emergency&#xD;
      Situations). PedAMINES™ is designed to support nurses step-by-step from order to delivery of&#xD;
      a wide range of drugs, especially those requiring continuous infusion. PedAMINES™ has already&#xD;
      been shown in a single-center simulation-based study to reduce time to vasoactive drug&#xD;
      preparation, to delivery and the rate of medication errors [2].&#xD;
&#xD;
      On the day of participation, after obtaining nurse's written informed consent and&#xD;
      randomization, nurses will receive a standardized 5-minute training session on how to use the&#xD;
      app. Then, the nurses will be asked to perform a standardized 15-minute highly realistic CPR&#xD;
      scenario, including post-return of spontaneous circulation (ROSC). After epinephrine-induced&#xD;
      ROSC, nurses will be asked to first prepare a continuous infusion of dopamine, using either&#xD;
      PedAMINES™ or a conventional method, and then a continuous infusion of norepinephrine by&#xD;
      crossing the procedure. Moreover, 2 questionnaires will be given before and after the&#xD;
      scenario to ask the nurses about their demographics data, perceived stress and degree of&#xD;
      satisfaction.&#xD;
&#xD;
        1. Primary outcome will be to measure in each allocation group the number of medication&#xD;
           dosage errors committed during each drug preparation sequence until injection.&#xD;
&#xD;
        2. Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug&#xD;
           delivery (TDD).&#xD;
&#xD;
      All the actions (i.e. primary and secondary outcomes) performed by the nurses during the&#xD;
      scenario will be automatically recorded and stored by the responsive simulator detectors, the&#xD;
      application and by several video cameras. To avoid assessment bias, two evaluators will then&#xD;
      independently review these video recordings. In case of disagreement, a third independent&#xD;
      evaluator will help reach a consensus.&#xD;
&#xD;
      We aim to determine whether the use of PedAMINES™ might improve the management of acute&#xD;
      life-threatening conditions by quickly delivering expertise in vasoactive drugs&#xD;
      administration in other hospitals in Switzerland, even in non-university hospitals where&#xD;
      nurses (and physicians) are either little or not exposed to pediatric CPRs. We hypothesize&#xD;
      that PedAMINES™ might primary reduce medication errors, and secondary reduce delays to drugs&#xD;
      preparation and delivery independently of the existing conventional preparation methods or&#xD;
      nurses' skills.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Blinding to the purpose of the study during recruitment will be maintained to minimize preparation bias. Nurses will be &quot;unblinded&quot; when the simulated scenario start.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Medication dosage errors</measure>
    <time_frame>On the day of study participation</time_frame>
    <description>To measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to drug preparation (TDP) and time to drug delivery (TDD)</measure>
    <time_frame>On the day of study participation</time_frame>
    <description>To measure in each allocation group the elapsed time in seconds between the oral prescription by the physician to drug preparation completion by the nurse (TDP) and to drug delivery (TDD) by the nurse.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Resuscitation</condition>
  <condition>Pediatrics</condition>
  <arm_group>
    <arm_group_label>Arm A (PedAMINES™ / Conventional Method)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of PedAMINES™ first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of a Conventional Method.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (Conventional Method / PedAMINES™)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of a Conventional Method first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of PedAMINES™.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PedAMINES™ / Conventional Method</intervention_name>
    <description>Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design:&#xD;
• PedAMINES™ (Period 1) and then Conventional Method (Period 2)</description>
    <arm_group_label>Arm A (PedAMINES™ / Conventional Method)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Method / PedAMINES™</intervention_name>
    <description>Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design:&#xD;
• Conventional Method (Period 1) and then PedAMINES™ (Period 2)</description>
    <arm_group_label>Arm B (Conventional Method / PedAMINES™)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be nurse certified&#xD;
&#xD;
          -  To know how to prepare intravenous drugs injection.&#xD;
&#xD;
          -  To have previously completed the 5-minute introductory course to the use of PedAMINES&#xD;
             dispensed by the investigators of the study.&#xD;
&#xD;
          -  Participation agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To have at any time undergone a previous experiment with a cognitive numeric device&#xD;
             aimed to help vasoactive drugs preparation.&#xD;
&#xD;
          -  To have not undergone the 5-minute introductory course to the use of PedAMINES.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johan N Siebert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geneva Children Hospital, Geneva University Hospitals, Geneva, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital du Valais</name>
      <address>
        <city>Sion</city>
        <state>Valais</state>
        <zip>1950</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de l'Enfance (HEL)</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HFR Fribourg</name>
      <address>
        <city>Fribourg</city>
        <zip>1752</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geneva Children's Hospital, Geneva University Hospitals</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Neuchâtelois</name>
      <address>
        <city>Neuchâtel</city>
        <zip>2000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Matos RI, Watson RS, Nadkarni VM, Huang HH, Berg RA, Meaney PA, Carroll CL, Berens RJ, Praestgaard A, Weissfeld L, Spinella PC; American Heart Association's Get With The Guidelines-Resuscitation (Formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Duration of cardiopulmonary resuscitation and illness category impact survival and neurologic outcomes for in-hospital pediatric cardiac arrests. Circulation. 2013 Jan 29;127(4):442-51. doi: 10.1161/CIRCULATIONAHA.112.125625. Epub 2013 Jan 22.</citation>
    <PMID>23339874</PMID>
  </reference>
  <reference>
    <citation>Siebert JN, Ehrler F, Combescure C, Lacroix L, Haddad K, Sanchez O, Gervaix A, Lovis C, Manzano S. A Mobile Device App to Reduce Time to Drug Delivery and Medication Errors During Simulated Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial. J Med Internet Res. 2017 Feb 1;19(2):e31. doi: 10.2196/jmir.7005.</citation>
    <PMID>28148473</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 29, 2018</last_update_submitted>
  <last_update_submitted_qc>January 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Johan Siebert</investigator_full_name>
    <investigator_title>MD: Emergency Physician</investigator_title>
  </responsible_party>
  <keyword>Medication errors</keyword>
  <keyword>Resuscitation</keyword>
  <keyword>Drugs</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Biomedical technology</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be deidentified and the study investigators will house the data locally on secure hard disk drives (HDD) at the Geneva Children's Hospital. Data will be freely available to anyone upon request 1 year after study completion. Only deidentified/anonymized data will be shared.</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/NCT03021122
org study id: SNSF_32003B_169348
nct id: NCT03021122
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or
      divisions to prepare continuous infusions of vasoactive drugs during a simulation-based
      pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to
      prepare and deliver vasoactive drugs following their current conventional methods or by the
      aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them
      step-by-step from order to delivery of these drugs.

        1. Primary outcome will be to measure in each allocation group the number of medication
           dosage errors committed during each drug preparation sequence until injection.

        2. Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug
           delivery (TDD).
During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for
      continuous infusion is both complex and time-consuming, placing children at higher risk than
      adults for medication errors. It is well established that CPR duration is inversely
      correlated to survival, decreasing linearly by 2.1 % per minute, and to decreased risk of
      neurological sequelae [1].

      In this study, the investigators recruit nurses working in 5 swiss Pediatric Emergency
      Departments or divisions to prepare continuous infusions of vasoactive drugs during a
      simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin (Laerdal
      SimJunior™). The scenario will take place in the shock room to increase realism.

      According to randomization with a 1:1 allocation ratio, nurses will have to prepare and
      deliver vasoactive drugs following their current conventional methods or by the aim of a
      mobile tablet application called PedAMINES™ (Pediatric Accurate Medication In Emergency
      Situations). PedAMINES™ is designed to support nurses step-by-step from order to delivery of
      a wide range of drugs, especially those requiring continuous infusion. PedAMINES™ has already
      been shown in a single-center simulation-based study to reduce time to vasoactive drug
      preparation, to delivery and the rate of medication errors [2].

      On the day of participation, after obtaining nurse's written informed consent and
      randomization, nurses will receive a standardized 5-minute training session on how to use the
      app. Then, the nurses will be asked to perform a standardized 15-minute highly realistic CPR
      scenario, including post-return of spontaneous circulation (ROSC). After epinephrine-induced
      ROSC, nurses will be asked to first prepare a continuous infusion of dopamine, using either
      PedAMINES™ or a conventional method, and then a continuous infusion of norepinephrine by
      crossing the procedure. Moreover, 2 questionnaires will be given before and after the
      scenario to ask the nurses about their demographics data, perceived stress and degree of
      satisfaction.

        1. Primary outcome will be to measure in each allocation group the number of medication
           dosage errors committed during each drug preparation sequence until injection.

        2. Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug
           delivery (TDD).

      All the actions (i.e. primary and secondary outcomes) performed by the nurses during the
      scenario will be automatically recorded and stored by the responsive simulator detectors, the
      application and by several video cameras. To avoid assessment bias, two evaluators will then
      independently review these video recordings. In case of disagreement, a third independent
      evaluator will help reach a consensus.

      We aim to determine whether the use of PedAMINES™ might improve the management of acute
      life-threatening conditions by quickly delivering expertise in vasoactive drugs
      administration in other hospitals in Switzerland, even in non-university hospitals where
      nurses (and physicians) are either little or not exposed to pediatric CPRs. We hypothesize
      that PedAMINES™ might primary reduce medication errors, and secondary reduce delays to drugs
      preparation and delivery independently of the existing conventional preparation methods or
      nurses' skills.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Blinding to the purpose of the study during recruitment will be maintained to minimize preparation bias. Nurses will be "unblinded" when the simulated scenario start.
measure: Medication dosage errors
time frame: On the day of study participation
description: To measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
measure: Time to drug preparation (TDP) and time to drug delivery (TDD)
time frame: On the day of study participation
description: To measure in each allocation group the elapsed time in seconds between the oral prescription by the physician to drug preparation completion by the nurse (TDP) and to drug delivery (TDD) by the nurse.
arm group label: Arm A (PedAMINES™ / Conventional Method)
arm group type: Experimental
description: A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of PedAMINES™ first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of a Conventional Method.
arm group label: Arm B (Conventional Method / PedAMINES™)
arm group type: Active Comparator
description: A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of a Conventional Method first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of PedAMINES™.
intervention type: Device
intervention name: PedAMINES™ / Conventional Method
description: Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design:
• PedAMINES™ (Period 1) and then Conventional Method (Period 2)
arm group label: Arm A (PedAMINES™ / Conventional Method)
intervention type: Device
intervention name: Conventional Method / PedAMINES™
description: Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design:
• Conventional Method (Period 1) and then PedAMINES™ (Period 2)
arm group label: Arm B (Conventional Method / PedAMINES™)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Johan N Siebert, MD
role: Principal Investigator
affiliation: Geneva Children Hospital, Geneva University Hospitals, Geneva, Switzerland
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Switzerland
citation: Matos RI, Watson RS, Nadkarni VM, Huang HH, Berg RA, Meaney PA, Carroll CL, Berens RJ, Praestgaard A, Weissfeld L, Spinella PC; American Heart Association's Get With The Guidelines-Resuscitation (Formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Duration of cardiopulmonary resuscitation and illness category impact survival and neurologic outcomes for in-hospital pediatric cardiac arrests. Circulation. 2013 Jan 29;127(4):442-51. doi: 10.1161/CIRCULATIONAHA.112.125625. Epub 2013 Jan 22.
PMID: 23339874
citation: Siebert JN, Ehrler F, Combescure C, Lacroix L, Haddad K, Sanchez O, Gervaix A, Lovis C, Manzano S. A Mobile Device App to Reduce Time to Drug Delivery and Medication Errors During Simulated Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial. J Med Internet Res. 2017 Feb 1;19(2):e31. doi: 10.2196/jmir.7005.
PMID: 28148473
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Johan Siebert
investigator title: MD: Emergency Physician
sharing ipd: Yes
ipd description: IPD will be deidentified and the study investigators will house the data locally on secure hard disk drives (HDD) at the Geneva Children's Hospital. Data will be freely available to anyone upon request 1 year after study completion. Only deidentified/anonymized data will be shared.