Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05391256 |
| Other study ID # |
DRILL4 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
May 31, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Karolinska Institutet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
