Out-Of-Hospital Cardiac ArrestNCT04415398
AED-delivery Using Drones in Out-of-hospital Cardiac Arrest
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 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… 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
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2020to 30 Sep 2020
- 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
- Within n=3 service areas
- Hours of operation: 08:00-22:00
Who cannot join
- Children <8 years
- Trauma
- EMS-witnessed cases
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
Read the detailed description
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:
- 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 (%)
- 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 (%)
- 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.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Automated flying Drone carrying an Automated external defibrillator (AED)
- Keywords
- Drone, 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=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.
| Study group | Role | What they receive |
|---|---|---|
| Delivery of automated external defibrillators using drones | Experimental | 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 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 suspected OHCA cases (%) where the AED-drone was dispatched and accurately completed mission.
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.
Measured: Up to 4 months
Secondary outcomes (3)
Proportion of suspected OHCA with AED-drone arrival prior to ambulance
Comparisons on proportion of units arriving first to the scene for ambulance vs AED-drone, percentages.
Measured: Up to 4 months
Time difference of drone arrival as compared to ambulance
Time delay from dispatch to arrival (delivered AED on ground), minutes, seconds.
Measured: Up to 4 months
Proportion/numbers of attached drone delivered AEDs prior the arrival of EMS (%).
A bystander retrieves the AED as instructed in T-CPR protocol by the dispatcher and attaches it to the patient before ambulance arrival. Percentages.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jun 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- SOS Alarm Sverige AB, Everdrone AB
- Responsible party
- Principal investigator, Andreas Claesson, Karolinska Institutet
- Investigators
- Andreas Claesson, PhD, Principal investigator, Centre for resuscitation science, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415398
- Sponsor's protocol ID
- AC1
- Status last verified
- Oct 2020
- First submitted
- 26 May 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schierbeck S, Hollenberg J, Nord A, Svensson L, Nordberg P, Ringh M, Forsberg S, Lundgren P, Axelsson C, Claesson A. Automated external defibrillators delivered by drones to patients with suspected out-of-hospital cardiac arrest. Eur Heart J. 2022 Apr 14;43(15):1478-1487. doi: 10.1093/eurheartj/ehab498.
PubMed 34438449
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04415398
- Acronym / sponsor ID
- AC1
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Drone, UAV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- SOS Alarm Sverige AB, Everdrone AB
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 4 Jun 2020 (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 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
Detailed description
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:
- 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 (%)
- 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 (%)
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Delivery of automated external defibrillators using drones | Experimental | Device: Automated flying Drone carrying an Automated external defibrillator (AED)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 |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All suspected OHCA
- Within n=3 service areas
- Hours of operation: 08:00-22:00
Key exclusion criteria (3 listed)
- Children <8 years
- Trauma
- EMS-witnessed cases
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=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. | Device | Delivery of automated external defibrillators using drones |
Primary outcome
Proportion of suspected OHCA cases (%) where the AED-drone was dispatched and accurately completed mission.
Time frame: Up to 4 months
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.
3 secondary outcomes
Proportion of suspected OHCA with AED-drone arrival prior to ambulance
Time frame: Up to 4 months
Time difference of drone arrival as compared to ambulance
Time frame: Up to 4 months
Proportion/numbers of attached drone delivered AEDs prior the arrival of EMS (%).
Time frame: Up to 4 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 5 Oct 2020.
- Derived from this study: PubMed 34438449Schierbeck S, Hollenberg J, Nord A, Svensson L, Nordberg P, Ringh M, Forsberg S, Lundgren P, Axelsson C, Claesson A. Automated external defibrillators delivered by drones to patients with suspected out-of-hospital cardiac arrest. Eur Heart J. 2022 Apr 14;43(15):1478-1487. doi: 10.1093/eurheartj/ehab498.
- 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.
Andreas Claesson, PhD principal investigator
Centre for resuscitation science, Karolinska Institutet
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 3 inclusion and 3 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 5 Oct 2020. 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 suspected OHCA cases (%) where the AED-drone was dispatched and accurately completed mission. (time frame: Up to 4 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 NCT04415398, 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 5 Oct 2020.