NCT04723368

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 21, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

January 18, 2021

Last Update Submit

June 3, 2022

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

DroneAEDOHCAEMSDispatch centreUAV

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 14 months

Secondary Outcomes (3)

  • Median time difference (min:sec) between AED-drone and ambulance.

    Up to 14 months

  • c) Proportion (%) of attached drone delivered AEDs prior the arrival of EMS. Percentages.

    Up to 14 months

  • d) Proportion (%) of cases defibrillated when a drone delivers an AED before ambulance arrival (real OHCA)

    Up to 14 months

Study Arms (1)

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.

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

Interventions

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.

Automated flying Drone carrying an Automated external defibrillator (AED)

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pre-alert:
  • Children \<8 years
  • Trauma
  • EMS-witnessed cases
  • Post alert:
  • ATC non-approval of flight
  • Rain, winds exceeding 8m/s (median)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Resuscitation science

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 38000871DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 25, 2021

Study Start

April 21, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

June 6, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)