NCT05391256

Brief Summary

Time to defibrillation is the most important predictor of survival in cardiac arrest. Recent studies have shown that unmanned drones can deliver AEDs to the site of real life out-of hospital cardiac arrest (OHCA) before ambulance arrival. Although an AED is available in the close vicinity, they are seldom used. The overall aim of this study is to provide an interventional bundle directed towards the dispatch centre and evaluate referral of callers to retrieve drone-delivered AEDs so that they may be attached in cases out-of-hospital cardiac arrest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

May 20, 2022

Last Update Submit

October 3, 2023

Conditions

Keywords

DroneAEDEMSOHCAUAVDispatch centre

Outcome Measures

Primary Outcomes (1)

  • Proportion (percent) of cases where a bystander attaches a drone-delivered AED to the OHCA- patients chest, prior the arrival of EMS.

    In all alerts to suspected OHCA where a drone took off and delivered an AED on the ground, all cases were a bystander attaches the drone delivered AED to the OHCA-patients chest as instructed in T-CPR protocol before ambulance arrival will be measured. In all alerts to suspected OHCA where a drone took off and delivered an AED on the ground, all cases were a bystander attaches the drone delivered AED to the OHCA-patients chest as instructed in T-CPR protocol before ambulance arrival will be measured. Percentages.

    Up to 12 months

Secondary Outcomes (2)

  • Proportion (percent) of cases where a dispatcher verbally refers a bystander to retrieve a drone-delivered AED on the ground before EMS arrival in cases of OHCA

    Up to 12 months

  • Proportion (percent) of cases where a bystander successfully retrieves a drone-delivered AED from the ground as instructed by the dispatcher.

    Up to 12 months

Study Arms (1)

Automated flying Drone carrying an Automated external defibrillator (AED)

EXPERIMENTAL

Totally six drone systems are setup to be deployed in suspected OHCA cases as a complement to EMS. This is a single-arm intervention evaluating referral of bystanders during 112-calls to retrieve drone delivered AEDs in suspected OHCA.

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

Interventions

Totally n=6 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 12 months 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. An interventional package directed to the dispatchers is distributed and consists of an e-learning program, an AED -trainer placed at the dispatch center. Within the dispatcher decision tool - there is information how to inform the caller to retrieve the AED. The HEMS-coordinator reminds the dispatcher during the call on operational information. Monthly information to staff of project progress is provided.

Automated flying Drone carrying an Automated external defibrillator (AED)

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
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 (2)

Region Jämtland

Östersund, Jämtland County, Sweden

Location

Västra Götalandsregionen

Gothenburg, VGRegion, Sweden

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Andreas Claesson, Ph.D

    Department of Clinical Science and Education, Södersjukhuset, Karolinska institutet

    PRINCIPAL INVESTIGATOR

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
Associate Professor

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

June 1, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations