AED-delivery Using Drones in Out-of-hospital Cardiac Arrest

NCT04415398 | Completed DMC

• 1 other identifier: AC1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Drone; UAV

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 4 months

Secondary Outcomes (3)

• Proportion of suspected OHCA with AED-drone arrival prior to ambulance

  Up to 4 months

• Time difference of drone arrival as compared to ambulance

  Up to 4 months

• Proportion/numbers of attached drone delivered AEDs prior the arrival of EMS (%).

  Up to 4 months

Study Arms (1)

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

Device: Automated flying Drone carrying an Automated external defibrillator (AED)

Interventions

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.

Delivery of automated external defibrillators using drones

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All suspected OHCA
• Within n=3 service areas
• Hours of operation: 08:00-22:00

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• SOS Alarm Sverige AB: collaborator
• Everdrone AB: collaborator

Study Sites (1)

Göteborg AED-drone service areas

Gothenburg, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34438449 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Andreas Claesson, PhD

  Centre for resuscitation science, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Totally n=3 AED-drones are deployed as a complement to standard care (EMS) in all cases of suspected OHCA occurring within service areas

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)