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AED-delivery Using Drones in Suspected OHCA

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ClinicalTrials.gov Identifier: NCT04723368
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : April 23, 2021
Sponsor:
Collaborators:
SOS Alarm Sverige AB
Everdrone AB
Vastra Gotaland Region
Aviation capacity resources AB (ACR)
Castellum AB
Information provided by (Responsible Party):
Andreas Claesson, Karolinska Institutet

Brief Summary:
Time to defibrillation is the most important predictor of survival in cardiac arrest. Traditional emergency medical system response is often to slow. The overall aim of this pilot study is to evaluate if drones can deliver Automated external defibrillators (AEDs) to the scene of suspected out-of-hospital cardiac arrest (OHCA) prior to ambulance arrival with clinically relevant time benefits.

Condition or disease Intervention/treatment Phase
Out-Of-Hospital Cardiac Arrest Device: Automated flying Drone carrying an Automated external defibrillator (AED) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AED-delivery Using Drones in Suspected Out-of-hospital Cardiac Arrest
Actual Study Start Date : April 21, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Automated flying Drone carrying an Automated external defibrillator (AED)
Five drone systems are setup to be deployed in suspected OHCA cases as a complement to EMS. This is a single-arm intervention evaluating time benefit of drone delivery of AEDs in suspected OHCA.
Device: Automated flying Drone carrying an Automated external defibrillator (AED)
Totally n=5 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 up to 9 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.




Primary Outcome Measures :
  1. Proportion (%) of AED-drone arrival prior to ambulance. [ Time Frame: Up to 9 months ]

    In all alerts of suspected OHCA where a drone took off, comparisons will be done on proportion (%) of AED-drones arriving first on scene vs the proportion (%) of ambulances arriving first on scene.

    Accurate completion of mission is defined as delivery of an AED onsite on the ground in close connection from the OHCA and drone operator reporting arrival status "F" back to the dispatch centre. AEDs shall be accessible to the bystander through T-CPR instructions given by the dispatcher.



Secondary Outcome Measures :
  1. Median time difference (min:sec) between AED-drone and ambulance. [ Time Frame: Up to 9 months ]

    In all alerts of suspected OHCA where a drone took off, analysis of time benefit will be done in all cases when the AED-drone arrived first to the scene of a suspected OHCA.

    Median time difference (min:sec) between AED-drone and ambulance will be measured.

    Accurate completion of mission is defined as delivery of an AED onsite on the ground in close connection from the OHCA and drone operator reporting arrival status "F" back to the dispatch centre. Time benefit will be presented overall (% > 3minutes) as well as in continuous data intervals i.e. proportions in: 0-1 min, 1-2 min, 2-3 min, 3-4 min.


  2. c) Proportion (%) of attached drone delivered AEDs prior the arrival of EMS. Percentages. [ Time Frame: Up to 9 months ]
    In all alerts to suspected OHCA where a drone took off, a bystander retrieves the drone delivered AED as instructed in T-CPR protocol by the calltaker and attaches it to the patient before ambulance arrival. Percentages.

  3. d) Proportion (%) of cases defibrillated when a drone delivers an AED before ambulance arrival (real OHCA) [ Time Frame: Up to 9 months ]
    In all alerts to suspected OHCA where a drone took off, a bystander attached the AED to the patient as instructed in T-CPR protocol by the calltaker and administers a shock before ambulance arrival. Percentages.



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All suspected OHCA during 112-calls including drowning
  • Within prespecified administrative areas (excluding no delivery- and no-fly zones)
  • Hours of operation: 08:00-22:00 (daylight conditions)
  • Drone system online

Exclusion Criteria:

Pre-alert:

  • Children <8 years
  • Trauma
  • EMS-witnessed cases

Post alert:

  • ATC non-approval of flight
  • Rain, winds exceeding 8m/s (median)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723368


Contacts
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Contact: Andreas Claesson, PhD +46-70 494 05 46 Andreas.claesson@ki.se
Contact: Sofia Schierbeck, MD +46-76 337 52 52 sofia.schierbeck@ki.se

Locations
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Sweden
Center for Resuscitation science Recruiting
Stockholm, Sweden
Contact: Andreas Claesson, PhD         
Sponsors and Collaborators
Karolinska Institutet
SOS Alarm Sverige AB
Everdrone AB
Vastra Gotaland Region
Aviation capacity resources AB (ACR)
Castellum AB
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Responsible Party: Andreas Claesson, RN, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04723368    
Other Study ID Numbers: SS1
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Claesson, Karolinska Institutet:
Drone
AED
OHCA
EMS
Dispatch centre
UAV
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases