<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/NCT04415398</url>
  </required_header>
  <id_info>
    <org_study_id>AC1</org_study_id>
    <nct_id>NCT04415398</nct_id>
  </id_info>
  <brief_title>AED-delivery Using Drones in Out-of-hospital Cardiac Arrest</brief_title>
  <official_title>Fully Integrated Drone-system for Delivery of an Automated External Defibrillator (AED) in Out-of-hospital Cardiac Arrest (OHCA) Before the Arrival of Emergency Medical Services (EMS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SOS Alarm Sverige AB</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Everdrone AB</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</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>
      Time to defibrillation is the most important predictor of survival in cardiac arrest.&#xD;
      Traditional emergency medical system response is often to slow. The aim of this study is to&#xD;
      investigate the feasibility of drone systems that delivers Automated External Defibrillators&#xD;
      (AED) to the scene of suspected Out-of-Hospital Cardiac Arrests (OHCA).&#xD;
&#xD;
      This study will test the feasibility of real-life flights with drones carrying automated&#xD;
      external defibrillators (AEDs) to out-of-hospital cardiac arrest (OHCA) as a complement to&#xD;
      standard care i.e EMS&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will test the feasibility of dispatching an out of sight AED-drone system to real-life&#xD;
      OHCA in parallel with standard EMS dispatch. The study period is 5 months between May to&#xD;
      September 2020. The study area will be covered by three individual drone systems covering&#xD;
      some 80,000 inhabitants within the controlled airspace of Säve airport in Göteborg Sweden.&#xD;
      Each drone system will have a flight range of six km.&#xD;
&#xD;
      The first month of the study period will be used as run-in period and the drone systems are&#xD;
      dispatched for beyond visual line of sight (BVLOS) flights in a simulated fashion and&#xD;
      optimized to decrease delays and to log pre-specified system variables, adherence to&#xD;
      protocol, time delays, technological functionality, weather conditions, conflict in the&#xD;
      airspace.&#xD;
&#xD;
      During the following 4 months June-September 2020, drones will dispatched to real-life&#xD;
      suspected OHCA during daytime 08:00-22:00.&#xD;
&#xD;
      An EMS communication radio-unit is placed at the drone control center. In case of a suspected&#xD;
      OHCA in the service area and will be alerted by the dispatch centre (SOS alarm) when a&#xD;
      suspected OHCA is recognized during the 112-call.&#xD;
&#xD;
        -  The dispatcher identifies a cardiac arrest in the service areas&#xD;
&#xD;
        -  A pilot (from Everdrone) immediately initiates deployment protocol for the drone.&#xD;
&#xD;
        -  Parallel communication is made with the air traffic control (ATC) centre in order to&#xD;
           grant permit to deploy the drone with regards to the current weather and aviation&#xD;
           situation.&#xD;
&#xD;
        -  The drone then flies to the coordinates of the OHCA and delivers an AED at the scene&#xD;
           using a winch system&#xD;
&#xD;
        -  The AED may be attached to the patient by the bystander on scene&#xD;
&#xD;
      Development of the technology is made by Everdrone AB Göteborg and SOS Alarm AB (national&#xD;
      dispatch organisation) and parallel applications for certificates for the individual aircraft&#xD;
      and permits for beyond visual line of sight flights (BVLOS-flights) was granted by the&#xD;
      Swedish Transportation board on 27 April 2020.&#xD;
&#xD;
      The drone system is operated only during daytime 08:00-22:00 when the Airport Air traffic&#xD;
      control is open. Likewise deployment of the drone will not be made if there is a conflict in&#xD;
      the airspace with manned aircrafts. Rainy weather or winds exceeding 8 m/s prohibits flights&#xD;
      as well.&#xD;
&#xD;
      Feasibility is evaluated and measured from the following aspects:&#xD;
&#xD;
        1. Operational factors Weather: a) rain, b) wind c) other. Conflict in airspace: a) manned&#xD;
           aircraft b) unmanned aircraft. Obstacles prohibiting flight or delivery: a) constructed&#xD;
           b) natural Time from dispatch to to take- off (min:sec). Time from dispatch to arrival&#xD;
           (min:sec). Proportions are measured out of cases with a) Take-off b) no take-off c)&#xD;
           aborted missions (%)&#xD;
&#xD;
        2. Human resources Adherence to protocol by: a) Dispatcher b) Drone pilot c) Air traffic&#xD;
           leader. Proportions are measured out of cases with neglected protocol prohibiting&#xD;
           mission completion, a) no alerts b) no take off c) aborted missions (%)&#xD;
&#xD;
        3. Technological functionality Drone, winch, Network, AED, Hangar, navigational software,&#xD;
           global positioning system precision, Dispatch centre system (CoordCOM -Dispatch centre&#xD;
           automated alert).&#xD;
&#xD;
      Proportions are measured out of cases where technological functionality prohibited mission&#xD;
      completion a) no take-off b) aborted missions. (%)&#xD;
&#xD;
      Adverse advents (AE) and serious adverse events (SAE) in relation to AED-drone mission /use&#xD;
      will be logged continuously. An adverse event may be caused by drone crash or risc of injury&#xD;
      or death due to conflict in airspace or technological impairment.&#xD;
&#xD;
      An AE is considered serious if it:&#xD;
&#xD;
        -  Results in death&#xD;
&#xD;
        -  Is immediately life-threatening&#xD;
&#xD;
        -  Requires hospitalisation or prolongation of existing hospitalization&#xD;
&#xD;
        -  Results in persistent or significant disability or incapacity&#xD;
&#xD;
      Events that are related to the patient in cardiac arrest and would be expected in patients&#xD;
      undergoing attempted resuscitation should NOT be reported. These include:&#xD;
&#xD;
        -  Death&#xD;
&#xD;
        -  Hospitalisation&#xD;
&#xD;
        -  Persistent or significant disability or incapacity&#xD;
&#xD;
        -  Organ failure&#xD;
&#xD;
      All events categorised as serious must be reported to the study administration within 24&#xD;
      hours of becoming aware of the event.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Totally n=3 AED-drones are deployed as a complement to standard care (EMS) in all cases of suspected OHCA occurring within service areas</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of suspected OHCA cases (%) where the AED-drone was dispatched and accurately completed mission.</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>All cases of OHCA within the three service areas where the dispatch centre alerts the drone-operator and the drone takes-off. Accurate completion of mission equals deliver an AED onsite on the ground within 50 meters from OHCA location. AEDs shall be accessible to the bystander through T-CPR instructions given by the dispatcher.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of suspected OHCA with AED-drone arrival prior to ambulance</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Comparisons on proportion of units arriving first to the scene for ambulance vs AED-drone, percentages.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time difference of drone arrival as compared to ambulance</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Time delay from dispatch to arrival (delivered AED on ground), minutes, seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion/numbers of attached drone delivered AEDs prior the arrival of EMS (%).</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>A bystander retrieves the AED as instructed in T-CPR protocol by the dispatcher and attaches it to the patient before ambulance arrival. Percentages.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Out-Of-Hospital Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Delivery of automated external defibrillators using drones</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three drone systems are setup to be deployed in suspected OHCA cases as a complement to EMS. This is a single-arm intervention evaluating feasibility in:&#xD;
Operational feasibility (Legislation, Weather conditions, conflict in airspace)&#xD;
Participant feasibility (Failure to respond; Dispatcher, Drone-pilot, Air traffic controller)&#xD;
Technological feasibility (Drone technology, software, winch-system , 4G network, radio communication</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Automated flying Drone carrying an Automated external defibrillator (AED)</intervention_name>
    <description>Totally n=3 drones are equipped with automated external defibrillators (AEDs). These drones are deployed by the dispatch centre to cases of suspected out-of-hospital cardiac (OHCA) as a complement to standard care (ambulance/EMS) over 4 months during daytime Monday to Sunday 08:00-22:00. The bystander onsite receives instructions from the dispatcher to retrieve the AED outside the house when it has been delivered by the drone. The bystander attaches the AED to the patients chest to facilitate early defibrillation.</description>
    <arm_group_label>Delivery of automated external defibrillators using drones</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All suspected OHCA&#xD;
&#xD;
          -  Within n=3 service areas&#xD;
&#xD;
          -  Hours of operation: 08:00-22:00&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children &lt;8 years&#xD;
&#xD;
          -  Trauma&#xD;
&#xD;
          -  EMS-witnessed cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Claesson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for resuscitation science, Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Göteborg AED-drone service areas</name>
      <address>
        <city>Göteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>October 1, 2020</last_update_submitted>
  <last_update_submitted_qc>October 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Andreas Claesson</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Drone</keyword>
  <keyword>UAV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Out-of-Hospital Cardiac Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04415398
org study id: AC1
nct id: NCT04415398
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Time to defibrillation is the most important predictor of survival in cardiac arrest.
      Traditional emergency medical system response is often to slow. The aim of this study is to
      investigate the feasibility of drone systems that delivers Automated External Defibrillators
      (AED) to the scene of suspected Out-of-Hospital Cardiac Arrests (OHCA).

      This study will test the feasibility of real-life flights with drones carrying automated
      external defibrillators (AEDs) to out-of-hospital cardiac arrest (OHCA) as a complement to
      standard care i.e EMS
We will test the feasibility of dispatching an out of sight AED-drone system to real-life
      OHCA in parallel with standard EMS dispatch. The study period is 5 months between May to
      September 2020. The study area will be covered by three individual drone systems covering
      some 80,000 inhabitants within the controlled airspace of Säve airport in Göteborg Sweden.
      Each drone system will have a flight range of six km.

      The first month of the study period will be used as run-in period and the drone systems are
      dispatched for beyond visual line of sight (BVLOS) flights in a simulated fashion and
      optimized to decrease delays and to log pre-specified system variables, adherence to
      protocol, time delays, technological functionality, weather conditions, conflict in the
      airspace.

      During the following 4 months June-September 2020, drones will dispatched to real-life
      suspected OHCA during daytime 08:00-22:00.

      An EMS communication radio-unit is placed at the drone control center. In case of a suspected
      OHCA in the service area and will be alerted by the dispatch centre (SOS alarm) when a
      suspected OHCA is recognized during the 112-call.

        -  The dispatcher identifies a cardiac arrest in the service areas

        -  A pilot (from Everdrone) immediately initiates deployment protocol for the drone.

        -  Parallel communication is made with the air traffic control (ATC) centre in order to
           grant permit to deploy the drone with regards to the current weather and aviation
           situation.

        -  The drone then flies to the coordinates of the OHCA and delivers an AED at the scene
           using a winch system

        -  The AED may be attached to the patient by the bystander on scene

      Development of the technology is made by Everdrone AB Göteborg and SOS Alarm AB (national
      dispatch organisation) and parallel applications for certificates for the individual aircraft
      and permits for beyond visual line of sight flights (BVLOS-flights) was granted by the
      Swedish Transportation board on 27 April 2020.

      The drone system is operated only during daytime 08:00-22:00 when the Airport Air traffic
      control is open. Likewise deployment of the drone will not be made if there is a conflict in
      the airspace with manned aircrafts. Rainy weather or winds exceeding 8 m/s prohibits flights
      as well.

      Feasibility is evaluated and measured from the following aspects:

        1. Operational factors Weather: a) rain, b) wind c) other. Conflict in airspace: a) manned
           aircraft b) unmanned aircraft. Obstacles prohibiting flight or delivery: a) constructed
           b) natural Time from dispatch to to take- off (min:sec). Time from dispatch to arrival
           (min:sec). Proportions are measured out of cases with a) Take-off b) no take-off c)
           aborted missions (%)

        2. Human resources Adherence to protocol by: a) Dispatcher b) Drone pilot c) Air traffic
           leader. Proportions are measured out of cases with neglected protocol prohibiting
           mission completion, a) no alerts b) no take off c) aborted missions (%)

        3. Technological functionality Drone, winch, Network, AED, Hangar, navigational software,
           global positioning system precision, Dispatch centre system (CoordCOM -Dispatch centre
           automated alert).

      Proportions are measured out of cases where technological functionality prohibited mission
      completion a) no take-off b) aborted missions. (%)

      Adverse advents (AE) and serious adverse events (SAE) in relation to AED-drone mission /use
      will be logged continuously. An adverse event may be caused by drone crash or risc of injury
      or death due to conflict in airspace or technological impairment.

      An AE is considered serious if it:

        -  Results in death

        -  Is immediately life-threatening

        -  Requires hospitalisation or prolongation of existing hospitalization

        -  Results in persistent or significant disability or incapacity

      Events that are related to the patient in cardiac arrest and would be expected in patients
      undergoing attempted resuscitation should NOT be reported. These include:

        -  Death

        -  Hospitalisation

        -  Persistent or significant disability or incapacity

        -  Organ failure

      All events categorised as serious must be reported to the study administration within 24
      hours of becoming aware of the event.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Totally n=3 AED-drones are deployed as a complement to standard care (EMS) in all cases of suspected OHCA occurring within service areas
primary purpose: Other
masking: None (Open Label)
measure: Proportion of suspected OHCA cases (%) where the AED-drone was dispatched and accurately completed mission.
time frame: Up to 4 months
description: All cases of OHCA within the three service areas where the dispatch centre alerts the drone-operator and the drone takes-off. Accurate completion of mission equals deliver an AED onsite on the ground within 50 meters from OHCA location. AEDs shall be accessible to the bystander through T-CPR instructions given by the dispatcher.
measure: Proportion of suspected OHCA with AED-drone arrival prior to ambulance
time frame: Up to 4 months
description: Comparisons on proportion of units arriving first to the scene for ambulance vs AED-drone, percentages.
measure: Time difference of drone arrival as compared to ambulance
time frame: Up to 4 months
description: Time delay from dispatch to arrival (delivered AED on ground), minutes, seconds.
measure: Proportion/numbers of attached drone delivered AEDs prior the arrival of EMS (%).
time frame: Up to 4 months
description: A bystander retrieves the AED as instructed in T-CPR protocol by the dispatcher and attaches it to the patient before ambulance arrival. Percentages.
arm group label: Delivery of automated external defibrillators using drones
arm group type: Experimental
description: Three drone systems are setup to be deployed in suspected OHCA cases as a complement to EMS. This is a single-arm intervention evaluating feasibility in:
Operational feasibility (Legislation, Weather conditions, conflict in airspace)
Participant feasibility (Failure to respond; Dispatcher, Drone-pilot, Air traffic controller)
Technological feasibility (Drone technology, software, winch-system , 4G network, radio communication
intervention type: Device
intervention name: Automated flying Drone carrying an Automated external defibrillator (AED)
description: Totally n=3 drones are equipped with automated external defibrillators (AEDs). These drones are deployed by the dispatch centre to cases of suspected out-of-hospital cardiac (OHCA) as a complement to standard care (ambulance/EMS) over 4 months during daytime Monday to Sunday 08:00-22:00. The bystander onsite receives instructions from the dispatcher to retrieve the AED outside the house when it has been delivered by the drone. The bystander attaches the AED to the patients chest to facilitate early defibrillation.
arm group label: Delivery of automated external defibrillators using drones
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Claesson, PhD
role: Principal Investigator
affiliation: Centre for resuscitation science, Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Andreas Claesson
investigator title: Associate professor
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest
sharing ipd: No