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Out-Of-Hospital Cardiac ArrestNCT05391256

Referral of Callers to Retrieve Drone-delivered AEDs 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 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 years and olderHealthy volunteers can take part
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
55 participants
Where
2 sitesSweden
Study dates
1 Jun 2022to 31 May 2023
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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites
  • Västra Götalandsregionen

    Gothenburg, VGRegion

  • Region Jämtland

    Östersund, Jämtland County

Other trials in Sweden

About this study

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.

Read the detailed description

This is an observational, non-randomized single group assignment study with the primary purpose of evaluating Referral of callers to retrieve drone-delivered AEDs in out-of-hospital cardiac arrest.

Totally, six AED-equipped drones will be placed in hangars at six different sites covering a geographic area of about 230 km2 and approximately 150,000 inhabitants for dispatch to suspected cases of OHCA as a complement to standard care i.e., ambulance. By coordinating the operations with local Air Traffic Control (ATC), the risk of airspace conflicts, or in worst case collisions, is mitigated to an acceptable level.

The investigators estimate to enroll some 150 alerts and 60 participants during a study period of up to 12 months. The investigators will closely follow and study the potential of dispatcher referral of 112-callers to retrieve and use drone delivered AEDs prior ambulance arrival.

The drone operator, Everdrone, has integrated all software and hardware for the concept on the DJI Matrice 600 Pro drone. Examples of added features: an integrated Parachute Rescue System (validated by independent third party using the ASTM F3322 - 18 standard), a high precision sense and avoid system and a winching device to safely lower the AED to ground at delivery from 30 meters altitude. Furthermore, Everdrone AB has fully integrated their system and operational routines with the dispatch central, emergency medical services and aviation organizations. As a result from previous study (version 1.0) a number of hardware and software improvements have been made to the system (version 2.0).

Six hangars are setup at optimal locations in each of the six administrative areas. Hangars are large isolated tents 4x4 meters in where the drone is placed, remotely operated and surveiled by camera. Hangars are within fenced areas so that the public has no access. They are equipped with weather stations and an automated gate which automatically will open on alert.

When an emergency 112-call is answered it is indexed by the dispatcher depending on the patients condition. If an OHCA is suspected, the dispatcher indexes the event as a)"ongoing cardio-pulmonary resuscitation (CPR)" or b) "Unconscious with abnormal or absent breathing". If an emergency call is identified within administrative areas AND indexed as "a" or "b" an automated (not manual as with ambulance alerts) alert is sent via radio-alert to the drone operator. This triggers:

boot-up of the drone drone hangar gate opening route-planning of the mission weather condition confirmation remote pilot acceptance of the mission remote pilot calling ATC for takeoff approval

The drone system receives an alert from the dispatch center and the drone takes off from the hangar after approval from the drone pilot. For safety reasons all beyond visual line of sight (BVLOS) flights are done within the controlled airspace of Säve airport, Malöga airport and Östersund airport. Approval from ATC is granted for every single flight. Each flight will be carried out at 60-80 meters of altitude, have a preliminary maximum flight speed of 70 km/h, and a maximum range of 6 km one-way. The drone system is remotely deployed and surveiled from the drone operating center at Everdrone. The drone is dispatched alongside ambulance as a complement to standard care. The drone systems are designed to operate in dry conditions with median winds not exceeding 8 m/s and during both day and night conditions.

The AED used is an ultra-light AED (FRED Easyport from Schiller), weighting totally 800 grams with basket and siren. Upon arrival onsite the basket with the AED will be winched down from about 30 m altitude and delivered within 10 meters from the object i.e., the front door or onsite in public areas. Local AED drone support after completed mission includes electrode change battery test, potentially pic-up up the drone after dispatch by the Everdrone personnel.

Dispatch of the drone in suspected OHCA cases will be executed as a complement to standard care i.e., ambulance between 1 June 2022 to 31 May 2023, totally up to 12 months of full-scale real-life flights to suspected OHCA victims. Based on historical data of OHCA from the Swedish register for cardiopulmonary resuscitation (SRCR) and first ever dispatch of AED-equipped drones during 2020 the drone systems will be alerted in an estimated 150 cases (about 3 flights/ week) of suspected OHCA over the study period. Predefined exclusion criteria (rain, median wind > 8 m/s, high rise buildings >20m, pre-flight checklists not OK) will presumably prohibit flights, thus making an estimated 60 cases eligible for inclusion (i.e., drone takes off and delivers an AEDs in suspected OHCA.)

All cases where an AED is delivered by a drone prior to EMS arrival will be included in the study. An interventional package directed to the dispatchers is distributed from May 2022 and onwards 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 that the drone is on its way and after delivery of the AED and as well on operational information such as drop-spot. Monthly information to staff of project progress is provided.

The dispatcher will try to refer the caller to retrieve the drone-delivered AED, the bystander will be encouraged to physically collect/retrieve the AED so that it may be attached to the patient suffering from OHCA.

Dispatchers compliance to the routine of referring callers to retrieve the drone-delivered AED so that it may be attached to the patient is evaluated from start of the project June 2020 to May 2023. Interventions directed towards the dispatch center will be described in chronological order in relation to the outcome parameters proportion (percentages) of referral, retrieval and attachment of AEDs.

Being tested
Automated flying Drone carrying an Automated external defibrillator (AED)
Keywords
Drone, AED, EMS, OHCA, UAV, Dispatch centre
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=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.

Study groups in NCT05391256
Study groupRoleWhat they receive
Automated flying Drone carrying an Automated external defibrillator (AED)ExperimentalTotally 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.
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.

  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.

    Measured: Up to 12 months

Secondary outcomes (2)
  1. 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

    In all alerts to suspected OHCA where a drone took off and delivered an AED on the ground, the dispatcher verbally tries to refer the bystander to retrieve the drone delivered AED before ambulance arrival. Proportion of cases where the dispatcher tries to refer the caller is measures (percentages). Accurate completion of mission is defined as delivery of an AED onsite on the ground in close connection from the OHCA, AEDs is accessible to the bystander and the dispatcher refers the caller to retrieve the AED through T-CPR instructions.

    Measured: Up to 12 months

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

    In all alerts to suspected OHCA where a drone took off and delivered an AED on the ground, the bystander physically retrieves the drone-delivered AED as instructed by the dispatcher during T-CPR before ambulance arrival. All cases with successful retrieval of the AED will be measured (percentages).

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start1 Jun 2022
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05391256
Sponsor's protocol ID
DRILL4
Status last verified
Oct 2023
First submitted
20 May 2022
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 2 sites 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 4 inclusion and 7 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 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 (percent) of cases where a bystander attaches a drone-delivered AED to the OHCA- patients chest, prior the arrival of EMS. (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Oct 2023.

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