Out-Of-Hospital Cardiac ArrestNCT04723368
AED-delivery Using Drones in Suspected OHCA
A study testing Automated flying Drone carrying an Automated external defibrillator (AED) in people with Out-Of-Hospital Cardiac Arrest, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Automated flying Drone carrying an Automated external defibrillator (AED)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSweden
- Study dates
- 21 Apr 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pre-alert:
- Children <8 years
- Trauma
- EMS-witnessed cases
- Post alert:
- ATC non-approval of flight
- Rain, winds exceeding 8m/s (median)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AED-delivery Using Drones in Suspected Out-of-hospital Cardiac Arrest
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.
Read the detailed description
This is an observational, non-randomized single group assignment study with the primary purpose of evaluating proportion of AED-delivery prior to ambulance arrival and time benefits.
Totally, five AED-equipped drones will be placed in hangars at five different sites covering a geographic area of about 200 km2 and approximately 125,000 inhabitants for dispatch to suspected cases of OHCA as a complement to standard care i.e., ambulance. By coordinating the operations with local Air Traffic Control (ATC), the risk of airspace conflicts, or in worst case collisions, is mitigated to an acceptable level.
The investigators estimate to enroll some 80 alerts and 60 participants during a study period of up to 14 months. The investigators will closely follow and study the potential of delivering AEDs prior ambulance arrival and timesaving effects as compared to ambulance during a period of up to 14 months in which the investigators will follow and study the potential of delivering AEDs prior ambulance arrival and timesaving effects as compared to ambulance.
The drone operator, Everdrone, has integrated all software and hardware for the concept on the DJI Matrice 600 Pro drone. Examples of added features: an integrated Parachute Rescue System (validated by independent third party using the ASTM F3322 - 18 standard), a high precision sense and avoid system and a winching device to safely lower the AED to ground at delivery. Furthermore, Everdrone AB has fully integrated their system and operational routines with the dispatch central, emergency medical services and aviation organizations. As a result from the previous study (version 1.0) a number of hardware and software improvements have been made to the system (version 2.0):
Five hangars will be setup at optimal locations in each of the five administrative areas. Hangars are large isolated tents 4x4 meters in where the drone is placed, remotely operated and surveiled by camera. Hangars are within fenced areas so that the public has no access. They are equipped with weather stations and an automated gate which automatically will open on alert.
When an emergency 112-call is answered it is indexed by the dispatcher depending on the patients condition. If an OHCA is suspected, the dispatcher indexes the event as a)"ongoing cardio-pulmonary resuscitation (CPR)" or b) "Unconscious with abnormal or absent breathing". If an emergency call is identified within administrative areas AND indexed as "a" or "b" an automated (not manual as with ambulance alerts) alert is sent via radio-alert to the drone operator. This triggers:
- boot-up of the drone
- drone hangar gate opening
- route-planning of the mission
- weather condition confirmation
- remote pilot acceptance of the mission
- remote pilot calling ATC for takeoff approval
The drone system receives an alert from the dispatch center and the drone takes off from the hangar after approval from the drone pilot. For safety reasons all beyond visual line of sight (BVLOS) flights are done within the controlled airspace of Säve airport approval from ATC granted for every single flight. Each flight will be carried out at 60-80 meters of altitude, have a preliminary maximum flight speed of 70 km/h, and a maximum range of 6 km one-way. The drone system is remotely deployed and surveiled from the drone operating center at Everdrone Säve Airport, the drone is dispatched alongside ambulance as a complement to standard care. The drone systems are designed to operate in dry conditions with median winds not exceeding 8 m/s and primarily during daylight conditions.
The AED used is an ultra-light AED (FRED Easyport from Schiller), weighting totally 800 grams with basket and siren. Upon arrival onsite the basket with the AED will be winched down from about 30 m altitude and delivered within 10 meters from the object i.e., the front door or onsite in public areas. Local AED drone support after completed mission includes electrode change battery test, potentially pic-up up the drone after dispatch by the Everdrone personnel.
Dispatch of the drone in suspected OHCA cases will be executed as a complement to standard care i.e., ambulance between 21 April to 1 June 2022, totally up to 14 months of full-scale real-life flights to suspected OHCA victims. Based on historical data of OHCA from the Swedish register for cardiopulmonary resuscitation (SRCR) and first ever dispatch of AED-equipped drones during 2020 the drone systems will be alerted in an estimated 80 cases (about 3.5 flights/ week) of suspected OHCA over the study period. In about 25% of cases, predefined exclusion criteria (rain, median wind > 8 m/s, high rise buildings >20m, pre-flight checklists not OK) will presumably prohibit flights, thus making an estimated 60 cases eligible for inclusion (i.e., drone takes off to deliver AEDs in suspected OHCA.)
For more details about the methods please see the research protocol.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Automated flying Drone carrying an Automated external defibrillator (AED)
- Keywords
- Drone, AED, OHCA, EMS, Dispatch centre, UAV
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated flying Drone carrying an Automated external defibrillator (AED)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Automated flying Drone carrying an Automated external defibrillator (AED) | Experimental | 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. Receives: Device: Automated flying Drone carrying an Automated external defibrillator (AED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (%) of AED-drone arrival prior to ambulance.
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.
Measured: Up to 14 months
Secondary outcomes (3)
Median time difference (min:sec) between AED-drone and ambulance.
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.
Measured: Up to 14 months
c) Proportion (%) of attached drone delivered AEDs prior the arrival of EMS. Percentages.
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.
Measured: Up to 14 months
d) Proportion (%) of cases defibrillated when a drone delivers an AED before ambulance arrival (real OHCA)
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.
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start21 Apr 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- SOS Alarm Sverige AB, Everdrone AB, Vastra Gotaland Region, Aviation capacity resources AB (ACR), Castellum AB
- Responsible party
- Principal investigator, Andreas Claesson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723368
- Sponsor's protocol ID
- SS1
- Status last verified
- Jun 2022
- First submitted
- 18 Jan 2021
- Last updated
- 6 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schierbeck S, Nord A, Svensson L, Ringh M, Nordberg P, Hollenberg J, Lundgren P, Folke F, Jonsson M, Forsberg S, Claesson A. Drone delivery of automated external defibrillators compared with ambulance arrival in real-life suspected out-of-hospital cardiac arrests: a prospective observational study in Sweden. Lancet Digit Health. 2023 Dec;5(12):e862-e871. doi: 10.1016/S2589-7500(23)00161-9.
PubMed 38000871
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AED-delivery Using Drones in Suspected Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04723368
- Acronym / sponsor ID
- SS1
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Drone, AED, OHCA, EMS, Dispatch centre, UAV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- SOS Alarm Sverige AB, Everdrone AB, Vastra Gotaland Region, Aviation capacity resources AB (ACR), Castellum AB
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an observational, non-randomized single group assignment study with the primary purpose of evaluating proportion of AED-delivery prior to ambulance arrival and time benefits.
Totally, five AED-equipped drones will be placed in hangars at five different sites covering a geographic area of about 200 km2 and approximately 125,000 inhabitants for dispatch to suspected cases of OHCA as a complement to standard care i.e., ambulance. By coordinating the operations with local Air Traffic Control (ATC), the risk of airspace conflicts, or in worst case collisions, is mitigated to an acceptable level.
The investigators estimate to enroll some 80 alerts and 60 participants during a study period of up to 14 months. The investigators will closely follow and study the potential of delivering AEDs prior ambulance arrival and timesaving effects as compared to ambulance during a period of up to 14 months in which the investigators will follow and study the potential of delivering AEDs prior ambulance arrival and timesaving effects as compared to ambulance.
The drone operator, Everdrone, has integrated all software and hardware for the concept on the DJI Matrice 600 Pro drone. Examples of added features: an integrated Parachute Rescue System (validated by independent third party using the ASTM F3322 - 18 standard), a high precision sense and avoid system and a winching device to safely lower the AED to ground at delivery. Furthermore, Everdrone AB has fully integrated their system and operational routines with the dispatch central, emergency medical services and aviation organizations. As a result from the previous study (version 1.0) a number of hardware and software improvements have been made to the system (version 2.0):
Five hangars will be setup at optimal locations in each of the five administrative areas. Hangars are large isolated tents 4x4 meters in where the drone is placed, remotely operated and surveiled by camera. Hangars are within fenced areas so that the public has no access. They are equipped with weather stations and an automated gate which automatically will open on alert.
When an emergency 112-call is answered it is indexed by the dispatcher depending on the patients condition. If an OHCA is suspected, the dispatcher indexes the event as a)"ongoing cardio-pulmonary resuscitation (CPR)" or b) "Unconscious with abnormal or absent breathing". If an emergency call is identified within administrative areas AND indexed as "a" or "b" an automated (not manual as with ambulance alerts) alert is sent via radio-alert to the drone operator. This triggers:
- boot-up of the drone
- drone hangar gate opening
- route-planning of the mission
- weather condition confirmation
- remote pilot acceptance of the mission
- remote pilot calling ATC for takeoff approval
The drone system receives an alert from the dispatch center and the drone takes off from the hangar after approval from the drone pilot. For safety reasons all beyond visual line of sight (BVLOS) flights are done within the controlled airspace of Säve airport approval from ATC granted for every single flight. Each flight will be carried out at 60-80 meters of altitude, have a preliminary maximum flight speed of 70 km/h, and a maximum range of 6 km one-way. The drone system is remotely deployed and surveiled from the drone operating center at Everdrone Säve Airport, the drone is dispatched alongside ambulance as a complement to standard care. The drone systems are designed to operate in dry conditions with median winds not exceeding 8 m/s and primarily during daylight conditions.
The AED used is an ultra-light AED (FRED Easyport from Schiller), weighting totally 800 grams with basket and siren. Upon arrival onsite the basket with the AED will be winched down from about 30 m altitude and delivered within 10 meters from the object i.e., the front door or onsite in public areas. Local AED drone support after completed mission includes electrode change battery test, potentially pic-up up the drone after dispatch by the Everdrone personnel.
Dispatch of the drone in suspected OHCA cases will be executed as a complement to standard care i.e., ambulance between 21 April to 1 June 2022, totally up to 14 months of full-scale real-life flights to suspected OHCA victims. Based on historical data of OHCA from the Swedish register for cardiopulmonary resuscitation (SRCR) and first ever dispatch of AED-equipped drones during 2020 the drone systems will be alerted in an estimated 80 cases (about 3.5 flights/ week) of suspected OHCA over the study period. In about 25% of cases, predefined exclusion criteria (rain, median wind > 8 m/s, high rise buildings >20m, pre-flight checklists not OK) will presumably prohibit flights, thus making an estimated 60 cases eligible for inclusion (i.e., drone takes off to deliver AEDs in suspected OHCA.)
For more details about the methods please see the research protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Automated flying Drone carrying an Automated external defibrillator (AED) | Experimental | Device: 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Children <8 years
- Trauma
- EMS-witnessed cases
- ATC non-approval of flight
- Rain, winds exceeding 8m/s (median)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Automated flying Drone carrying an Automated external defibrillator (AED) |
Primary outcome
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.
3 secondary outcomes
Median time difference (min:sec) between AED-drone and ambulance.
Time frame: Up to 14 months
c) Proportion (%) of attached drone delivered AEDs prior the arrival of EMS. Percentages.
Time frame: Up to 14 months
d) Proportion (%) of cases defibrillated when a drone delivers an AED before ambulance arrival (real OHCA)
Time frame: Up to 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Derived from this study: PubMed 38000871Schierbeck S, Nord A, Svensson L, Ringh M, Nordberg P, Hollenberg J, Lundgren P, Folke F, Jonsson M, Forsberg S, Claesson A. Drone delivery of automated external defibrillators compared with ambulance arrival in real-life suspected out-of-hospital cardiac arrests: a prospective observational study in Sweden. Lancet Digit Health. 2023 Dec;5(12):e862-e871. doi: 10.1016/S2589-7500(23)00161-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated flying Drone carrying an Automated external defibrillator (AED) in people with Out-Of-Hospital Cardiac Arrest, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (%) of AED-drone arrival prior to ambulance. (time frame: Up to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04723368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.