AED-delivery Using Drones in Out-of-hospital Cardiac Arrest
Primary Purpose
Out-Of-Hospital Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Automated flying Drone carrying an Automated external defibrillator (AED)
Sponsored by
About this trial
This is an interventional other trial for Out-Of-Hospital Cardiac Arrest focused on measuring Drone, UAV
Eligibility Criteria
Inclusion Criteria:
- All suspected OHCA
- Within n=3 service areas
- Hours of operation: 08:00-22:00
Exclusion Criteria:
- Children <8 years
- Trauma
- EMS-witnessed cases
Sites / Locations
- Göteborg AED-drone service areas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Delivery of automated external defibrillators using drones
Arm 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Time difference of drone arrival as compared to ambulance
Time delay from dispatch to arrival (delivered AED on ground), minutes, seconds.
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.
Full Information
NCT ID
NCT04415398
First Posted
May 26, 2020
Last Updated
October 1, 2020
Sponsor
Karolinska Institutet
Collaborators
SOS Alarm Sverige AB, Everdrone AB
1. Study Identification
Unique Protocol Identification Number
NCT04415398
Brief Title
AED-delivery Using Drones in Out-of-hospital Cardiac Arrest
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
SOS Alarm Sverige AB, Everdrone AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest
Keywords
Drone, UAV
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delivery of automated external defibrillators using drones
Arm Type
Experimental
Arm 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(s)
Automated flying Drone carrying an Automated external defibrillator (AED)
Intervention 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.
Primary Outcome Measure Information:
Title
Proportion of suspected OHCA cases (%) where the AED-drone was dispatched and accurately completed mission.
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.
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Proportion of suspected OHCA with AED-drone arrival prior to ambulance
Description
Comparisons on proportion of units arriving first to the scene for ambulance vs AED-drone, percentages.
Time Frame
Up to 4 months
Title
Time difference of drone arrival as compared to ambulance
Description
Time delay from dispatch to arrival (delivered AED on ground), minutes, seconds.
Time Frame
Up to 4 months
Title
Proportion/numbers of attached drone delivered AEDs prior the arrival of EMS (%).
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.
Time Frame
Up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All suspected OHCA
Within n=3 service areas
Hours of operation: 08:00-22:00
Exclusion Criteria:
Children <8 years
Trauma
EMS-witnessed cases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Claesson, PhD
Organizational Affiliation
Centre for resuscitation science, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Göteborg AED-drone service areas
City
Göteborg
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34438449
Citation
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.
Results Reference
derived
Learn more about this trial
AED-delivery Using Drones in Out-of-hospital Cardiac Arrest
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