AED-delivery Using Drones in Suspected OHCA
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|ClinicalTrials.gov Identifier: NCT04723368|
Recruitment Status : Completed
First Posted : January 25, 2021
Last Update Posted : June 6, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Out-Of-Hospital Cardiac Arrest||Device: Automated flying Drone carrying an Automated external defibrillator (AED)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AED-delivery Using Drones in Suspected Out-of-hospital Cardiac Arrest|
|Actual Study Start Date :||April 21, 2021|
|Actual Primary Completion Date :||June 1, 2022|
|Actual Study Completion Date :||June 1, 2022|
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 14 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.
- Proportion (%) of AED-drone arrival prior to ambulance. [ Time Frame: Up to 14 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.
- Median time difference (min:sec) between AED-drone and ambulance. [ Time Frame: Up to 14 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.
- c) Proportion (%) of attached drone delivered AEDs prior the arrival of EMS. Percentages. [ Time Frame: Up to 14 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.
- d) Proportion (%) of cases defibrillated when a drone delivers an AED before ambulance arrival (real OHCA) [ Time Frame: Up to 14 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|
- 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
- Children <8 years
- EMS-witnessed cases
- ATC non-approval of flight
- Rain, winds exceeding 8m/s (median)
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
|Center for Resuscitation science|
|Responsible Party:||Andreas Claesson, RN, Associate professor, Karolinska Institutet|
|Other Study ID Numbers:||
|First Posted:||January 25, 2021 Key Record Dates|
|Last Update Posted:||June 6, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Out-of-Hospital Cardiac Arrest