A Mixed-methods Evaluation of Integrating Drone-delivered Automated External Defibrillators Into the Ambulance Service Response to Out-of-hospital Cardiac Arrest
Conditions: Cardiac Arrest, Out-Of-Hospital
Sponsor: University of Warwick

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PROTOCOL 
 
Drone-Delivered Defibrillators (The 3D Project) 
 
A mixed-methods evaluation of integrating drone-delivered Automated 
External Defibrillators into the ambulance service response to out-of-hospital 
cardiac arrest 
 
 
Sponsor: 
University of Warwick 
 
Funding Body:  
National Institute for Health and Care Research, Research for Patient Benefit 
 
Ethics Approval:  
NHS REC 
 
Version:  
3.0 
 
Date: 
27 February 2024 
 
 
 
 
 
 
 
 
 
 
 
 

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Contact Names 
 
Sponsor: 
 
 
University of Warwick 
Research Governance Team 
Research & Impact Services 
University House 
sponsorship@warwick.ac.uk  
 
Chief Investigator:  
Dr Christopher M Smith 
 
 
 
 
Warwick Clinical Trials Unit 
 
 
 
 
University of Warwick 
 
 
 
 
 
CV4 7AL 
 
 
 
 
Tel: 02476151083 
 
 
 
 
c.smith.12@warwick.ac.uk  
 
Co-investigators:  
Dr Keith Couper 
Warwick Clinical Trials Unit 
 
 
 
 
University of Warwick 
 
 
 
 
 
CV4 7AL  
 
Mr Mark Holt 
PPI representative 
 
Mrs Mary O’Sullivan 
PPI representative 
 
Mr Carl Powell 
Welsh Ambulance Services NHS Trust 
 
Dr Nigel Rees 
Welsh Ambulance Services NHS Trust 
Pre-Hospital Emergency Research Unit (PERU)  
Swansea University 

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Swansea 
SA2 8PP 
Tel: 07710152318 
 
Collaborator: 
 
Paul Lindup 
SkyBound Rescuer 
 
 

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TABLE OF CONTENTS 
 
List of abbreviations 
 
 
 
 
 
 
 
 
6 
 
1. BACKGROUND 
 
 
 
 
 
 
 
 
7 
1.1 Epidemiology and burden of out-of-hospital cardiac arrest 
 
7 
1.2 Drone-delivered defibrillators: existing knowledge 
 
 
8 
1.3 The need for this study  
 
 
 
 
 
 
10 
1.4 Ethical considerations  
 
 
 
 
 
 
11 
1.5 Study reporting  
 
 
 
 
 
 
 
12 
 
2. STUDY OVERVIEW 
 
 
 
 
 
 
 
 
13 
2.1 Overall aim and objectives 
 
 
 
 
 
 
13 
 
3. WORK PACKAGE 1  
 
 
 
 
 
 
 
15 
3.1 Objective  
 
 
 
 
 
 
 
 
15 
3.2 Approach and rationale  
 
 
 
 
 
 
15 
3.3 Study design 
 
 
 
 
 
 
 
 
15 
3.4 Participants and recruitment  
 
 
 
 
 
16 
3.5 Analyses  
 
 
 
 
 
 
 
 
19 
3.6 Ethical and safety considerations 
 
 
 
 
 
20 
 
4. WORK PACKAGE 2  
 
 
 
 
 
 
 
22 
4.1 Objectives  
 
 
 
 
 
 
 
 
22 
4.2 Development work 
 
 
 
 
 
 
 
22 
4.3 Approach and rationale  
 
 
 
 
 
 
23 
4.4 Study design 
 
 
 
 
 
 
 
 
24 
4.5 Participants and recruitment  
 
 
 
 
 
25 
4.6 Outcomes  
 
 
 
 
 
 
 
 
28 
4.7 Analyses  
 
 
 
 
 
 
 
 
29 
4.8 Ethical and safety considerations 
 
 
 
 
 
30 
 
5. DATA MANAGEMENT 
 
 
 
 
 
 
 
32 

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5.1 Data collection and management 
 
 
 
 
 
32 
5.2 Data storage 
 
 
 
 
 
 
 
 
33 
5.3 Data access and quality assurance  
 
 
 
 
33 
5.4 Data shared with third parties  
 
 
 
 
 
33 
5.5 Archiving  
 
 
 
 
 
 
 
 
34 
 
6. STUDY ORGANISATION 
 
 
 
 
 
 
 
35 
6.1 Sponsorship arrangements 
 
 
 
 
 
 
35 
6.2 Collaborators 
 
 
 
 
 
 
 
 
35 
6.3 Patient and public involvement 
 
 
 
 
 
35 
6.4 Ethical and regulatory approvals 
 
 
 
 
 
36 
6.5 Indemnity and insurance 
 
 
 
 
 
 
36 
6.6 Study timeline 
 
 
 
 
 
 
 
 
37 
6.7 Administration 
 
 
 
 
 
 
 
 
37 
6.8 Funding 
 
 
 
 
 
 
 
 
 
37 
6.9 Essential documentation 
 
 
 
 
 
 
38 
6.10 Intellectual property 
 
 
 
 
 
 
 
38 
 
7. DISSEMINATION AND IMPACT 
 
 
 
 
 
 
40 
 
8. REFERENCES  
 
 
 
 
 
 
 
 
41 
 
9. APPENDICES  
 
 
 
 
 
 
 
 
44 
 

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LIST OF ABBREVIATIONS 
 
ABBREVIATION 
EXPLANATION 
AED 
Automated External Defibrillator 
BVLOS 
Beyond Visual Line of Sight 
CAA 
Civil Aviation Authority 
CAQDAS 
Computer Assisted Qualitative Data Analysis 
COM-B 
Capability, Opportunity, Motivation – Behaviour model 
COREQ  
COnsolidated criteria for REporting Qualitative research 
CPR 
Cardiopulmonary Resuscitation 
CTU 
Clinical Trials Unit 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
HRA 
Health Research Authority 
IRAS 
Integrated Research Application System 
NIHR 
National Institute for Health and Care Research 
NHS 
National Health Service 
PPI 
Patient & Public Involvement 
REC 
Research Ethics Committee 
RfPB 
Research for Patient Benefit 
SOP 
Standard Operating Procedure 
STROBE 
Strengthening the Reporting of Observational Studies in 
Epidemiology 
TDF 
Theoretical Domains Framework 
UAV 
Unmanned Aerial Vehicle 
UK 
United Kingdom 
UTM 
Unified Traffic Management 
WAST 
Welsh Ambulance Service NHS Trust 
 
 
 
 

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1. BACKGROUND 
 
1.1 Epidemiology and burden of out-of-hospital cardiac arrest 
 
Globally, fewer than 10% people sustaining an out-of-hospital cardiac arrest survive to 
hospital discharge (1, 2). UK NHS Ambulance Services attempt resuscitation in 
approximately 30,000 people annually. The annual incidence in England is 57.9 per 
100,000 (2021 figures), with 8.5% surviving to hospital discharge (3) 
 
Early defibrillation and good-quality chest compressions during cardiopulmonary 
resuscitation (CPR) substantially increase the chance of surviving to hospital 
discharge (4). Defibrillation is time-critical: for every minute it is delayed survival 
chances fall 5-10% (5). 
 
The immediate community response to out-of-hospital cardiac arrest is therefore vital: 
of all possible interventions, prompt bystander CPR and bystander used of public-
access Automated External Defibrillators (AEDs) before an ambulance arrives make 
the most difference (4). 
 
Bystander intervention may be increasingly important as demand for NHS Ambulance 
Services increases year-on-year. In England, for example, ambulance services 
reached out-of-hospital cardiac arrest patients within seven minutes on only 47.5% 
occasions in 2021. The response time was at least 17.5 minutes for 10% patients 
(3). An earlier study reported substantially longer response times and worse patient 
outcomes in rural areas compared to urban areas in England (6). 
 
Public-access AED use, in particular, is associated with an approximate doubling of 
both survival to hospital discharge and survival with good neurological function 
(7). Median survival after bystander defibrillation is 53% (8). However, whilst 
bystanders performed CPR in 73.5% cases in England in 2021 they used an AED in 
only 5.5% cases (3) 
 
 

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1.2 Drone-delivered defibrillators: existing knowledge 
 
It is possible to use Unmanned Aerial Vehicles (UAVs, or ‘drones’) to carry an AED 
and deliver it to the site of an out-of-hospital cardiac arrest.  
 
Drones are already extensively used in the commercial sector and their safe operation 
is tightly regulated in the UK by the Civil Aviation Authority (CAA). There are few 
technical barriers to drone use, and the complexity concerning their use in this context 
relates to how best to use them to complement existing approaches to out-of-hospital 
cardiac arrest. 
 
Researchers in Canada (9, 10), Sweden (11), Germany (12) and USA (13) have 
demonstrated in modelling work that optimally-located drone bases could have 
delivered AEDs to patients (in historical cases) before an ambulance arrived. This time 
saving is largest in rural areas (9-11). In 18 actual test flights in Sweden, an AED-
equipped drone reached historical out-of-hospital cardiac arrests 16.4 minutes quicker 
(mean) than during the real event (14). 
 
A drone-delivered AED network is reality in Stockholm, Sweden. Between June–
September 2020, drone-delivered AEDs were available in three regions. Once an 
emergency call-handler identified an out-of-hospital cardiac arrest, there was an alert 
to a drone pilot. The pilot sought permission to fly from air-traffic control and remote-
piloted the drone to the scene. In 12 drone flights, a drone arrived at the scene 11 
times and arrived before the ambulance seven times (median time saving 1:52 
minutes) (15).  
 
There are many process issues to resolve. A drone-delivered AED was not attached 
to a patient on any occasion in this Stockholm pilot (15), albeit a case report from that 
system (December 2021) has now reported survival to hospital discharge in a patient 
defibrillated by a drone-delivered AED (16). 
 
In the Stockholm study, median time from emergency call to AED delivery was 9:08 
minutes, of which 3:10 minutes elapsed before drone launch (15). In simulations in 

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Germany it took a mean of 6:02 minutes to defibrillate the patient for the shortest (just 
0.4km) of five test-flight routes (12). Most delays to defibrillation therefore would have 
been before and/or after the drone flight. 
 
Once a drone delivers an AED, bystanders in simulations reported comfort in 
interacting with the drone (12, 17-19). 
 
In eight single-bystander simulations in Sweden, the hands-off CPR time (the time 
from stopping CPR to retrieve the AED to the time that CPR commences again once 
the AED has been attached and delivered a shock) was a mean of 94 seconds (range 
75-110 seconds) (17). 
 
Our research team has existing experience of carrying AEDs by drone, demonstrating 
the use of fixed-wing aircraft to carry an AED a total of 92km over six test flights in a 
coastal air corridor in Wales. The AED was dropped by parachute from 120m, and 
landed within 50m of the target location (20). 
 
We have subsequently developed a delivery system using a rotary-wing drone, 
demonstrating that we could carry an AED and safely lower it via winch at the exact 
location required (<5m) in simulated out-of-hospital cardiac arrests (19). Notably, the 
Stockholm team use a winch mechanism for their live operations (15, 16). 
 
In our latter study (19), participants made a simulated 999-call, performed CPR and 
were instructed that an AED would arrive via drone. Participants felt uncomfortable 
leaving the patient’s side and asked the 999-call-handler for permission to leave the 
patient - even though they had heard the AED's arrival and an audible siren indicating 
it was safe to approach. They appreciated that the cognitive burden of deciding 
whether or not to try and retrieve a distant AED had been removed from them. Hands-
off CPR time was a median 109 seconds (interquartile range 87-130 seconds) in 18 
simulations. However, only 19 seconds of this hands-off time was time actually away 
from the patient’s side: only a small addition to hands-off CPR time compared to a 
situation where an AED is placed directly in their hands by someone else. Drone-

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delivery of AEDs may therefore be appropriate for situations where there is only one 
bystander. 
 
In the UK, ‘Beyond Visual Line of Sight’ (BVLOS) drone flights are generally limited by 
the CAA to research studies in pre-agreed flight corridors. However, within these 
corridors there are opportunities to test drone carriage of AEDs. 
 
We are ready to demonstrate an optimised, fully-integrated drone-delivery system 
(from 999-call to AED attached to patient) to the CAA and to the public. This will put 
ambulance services across the UK in a position where they can test and implement 
drone-delivery AEDs as soon as possible. 
 
1.3  The need for this study 
 
Barriers to public-access AED use 
 
The NHS Long Term Plan aims to improve the public-access AED network to 
help save 4,000 additional lives each year from cardiac arrest, and to reduce health 
inequalities (21). However, public-access AEDs in the UK are not optimally nor 
equitably placed. AED density (per square-km) varies by geographical region (lowest 
in North-East England), by affluence (fewer in poorer areas) and by population density 
(fewer where residential density is higher) (22). Areas of low AED density 
correlate closely with areas of high out-of-hospital cardiac arrest incidence and low 
bystander CPR rates, further exacerbating this inequity (6). 
 
Our systematic review synthesised data from 68 studies to characterise facilitators and 
barriers to successful bystander AED use (23). Several key barriers relate to the static 
location of AEDs and the need for bystanders to leave a patient to retrieve one. 
 
The path to successful public-access AED is a complicated one. First, one must 
determine whether an AED is close enough to retrieve and use. Where only a single 
bystander is present, there is a need to balance benefits of early defibrillation against 
harms of not delivering prompt CPR. A bystander must be able to successfully locate, 

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retrieve and then use a public-access AED. Studies highlight that bystanders are often 
reluctant to leave a patient (24, 25), and the further away a patient is from a public-
access AED the less likely it is that one will be used (26). 
 
The importance of overcoming these barriers 
 
Direct delivery of AEDs via drone to members of the public attending an out-of-hospital 
cardiac arrest may be a way of overcoming the barriers to public-access AED use. 
Other countries have demonstrated the concept and there is real-world use in Sweden. 
Developing a system in the UK, and using the experience of others to optimise 
communications between ambulance services and drone operators, is an area ripe for 
immediate further study. 
 
Survival with favourable neurological outcome is an important outcome for both 
patients and their relatives (27). A recent collaboration between adult out-of-hospital 
cardiac arrest survivors, their families and the James Lind Alliance reported that 
optimising community interventions and focussing on longer-term impacts were top 
priorities (28). 
 
Early access to defibrillation by members of the public improves survival. More than 
this, those who do survive a cardiac arrest have better longer-term and functional 
outcomes if they received bystander defibrillation: they are less likely to have brain 
damage or require nursing-home care one year later (29), and are less likely to require 
intensive care admission (30). 
 
As cardiac arrest researchers we believe, therefore, that increasing timely bystander 
AED use can improve clinical outcomes and aligns well with survivor and family 
priorities.  
 
1.4 Ethical considerations 
 
We will conduct the study in full conformance with the principles of the Declaration of 
Helsinki and to Good Clinical Practice (GCP) guidelines. It will also comply with all 

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applicable UK legislation regarding Unmanned Aerial Vehicle (UAV) flights and all 
appropriate University of Warwick Standard Operating Procedures (SOPs). All data 
will be stored securely and held in accordance with the UK General Data Protection 
Regulation (GDPR). 
 
We detail specific ethical considerations for both work packages in the relevant 
sections.  
 
1.5 Study reporting 
 
We will make results of both work packages available in open-access peer-reviewed 
publications. 
 
We will report work package 1 according to COREQ (Consolidated criteria for reporting 
qualitative research) guidelines (31). 
 
We will report work package 2 (simulated cardiac arrests with BVLOS drone flight to 
deliver an AED) according to STROBE (Strengthening the Reporting of Observational 
Studies in Epidemiology) guidelines for observational studies (32) and its extension 
for simulation studies (33). 
 
 

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2. STUDY OVERVIEW 
 
This is an 18-month project (May 1st 2023 to October 31st 2024) split into two work 
packages, detailed in sections 3-4 of this protocol. It is funded by the National Institute 
for Health and Care Research (NIHR) Research for Patient Benefit (RfPB) funding 
programme.  
 
It involves collaboration between University Hospitals Coventry and Warwickshire  
NHS Trust (UHCW), University of Warwick, Welsh Ambulance Service NHS Trust 
(WAST) 
and 
SkyBound 
Rescuer 
(a 
commercial 
drone 
operator 
–  
https://skyboundrescuerproject.com/). There are two Patient and Public Involvement 
(PPI) representatives.  
 
2.1 Overall aim and objectives 
 
The aim of the project is to explore the optimisation and integration of a drone-
delivered AED system into the pre-hospital response to out-of-hospital cardiac arrest, 
as a necessary pre-requisite to real-life flight operations. 
 
Objectives: 
 
Objective I:  
Explore the attitudes of real-life out-of-hospital cardiac arrest 
bystanders, who may or may not have used an AED, about using 
drones to deliver AEDs. (Work package 1) 
Objective II:  
 Demonstrate capability for safe BVLOS flights of an AED-capable 
drone in controlled flight corridors. (Work package 2) 
Objective III: 
 Create compatible systems between drone operator and 
ambulance service; optimise automated drone-activation systems 
and flight start-up procedures once out-of-hospital cardiac arrest 
is identified during a 999 call. (Work package 2) 
Objective IV: 
 Demonstrate an AED drone-delivery system that is fully 
integrated with ambulance service systems, in ‘end-to-end’ (from 

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999 call to AED use on a patient) BVLOS flights for simulated out-
of-hospital cardiac arrests. (Work package 2) 
 

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3. WORK PACKAGE 1 
 
3.1 Objective 
 
Explore the attitudes of real-life out-of-hospital cardiac arrest bystanders, who may or 
may not have used an AED, about using drones to deliver an AED. 
 
3.2 Approach and rationale 
 
There is work in simulation studies suggesting that bystanders generally find it easy 
to interact with a drone that has delivered an AED to them (12, 17-19). In our previous 
simulation work participants experienced a few common issues (19), many of which 
involved their interaction with the 999 call-handler. They often felt uncertain about 
when it was safe to leave the patient to retrieve the AED, or felt uncomfortable in 
leaving the patient, despite audible prompts from the drone to indicate that it was 
indeed safe. They relied on feedback or ‘permission’ from the call-handler to allow 
them to do this. There were also difficulties in interacting with the AED itself – which 
has automated voice instructions helping people to use it – when 999 call-handler 
instructions conflicted and when the noise of the departing drone made it difficult to 
hear instructions. 
 
There is a need to investigate further the behaviours of people who have used or who 
may use an AED at an out-of-hospital cardiac arrest, particularly with regards to how 
they interact with the 999 call-handler. 
 
3.3 Study design 
 
We will conduct semi-structured interviews with people who have actively participated 
in an out-of-hospital cardiac arrest. We will conduct these remotely, either using a 
University of Warwick-managed computer and a Microsoft Teams account or via 
telephone. Participants will have the opportunity to conduct the Teams interview with 
their video on or off.   
 

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We will interview both those who have used an AED and those who did not. We will 
record age, gender, whether they have used an AED or not and whether they have 
had previous CPR/AED training or experience or not. We will explore their personal 
experiences, particularly in relation to: 
 
 
Their reasons for using / not using an AED. 
 
Their experience with the 999 call-handler and how we might optimise this. 
 
Their likely reaction to an AED being delivered to them by drone. 
 
How best to optimise their interaction with the drone-delivered AED with, again, 
particular focus on the interaction with the 999 call-handler. 
 
We anticipate that the interviews will last up to 45 minutes, and that we will interview 
each participant on one occasion. 
 
A senior research fellow, skilled in qualitative research, will undertake the interviews. 
The researcher will start with open questions and follow-up with prompting and more 
directed questions as needed (34). We have developed a Brief Topic Guide that 
focusses on aspects relating to the participants’ capability, opportunity and motivation 
(see explanations in section 3.5) to use an AED, interact successfully with a drone-
delivered AED and interact successfully with the 999 call-handler.   
 
3.4 Participants and recruitment 
 
We will recruit adults (> 18 years old) who: 
 
 have mental capacity to make decisions about study participation. 
 have provided bystander interventions (CPR +/- use of an AED) during an out-
of-hospital cardiac arrest.  
 are able to conduct interviews in English. 
 are willing to have an audio recording made of the interview. 
 
We will exclude people if it is clear that they have not previously provided any 
bystander intervention during an out-of-hospital cardiac arrest or if, in the judgement 

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of the interviewer, are not able to understand or communicate effectively in English. 
We will also exclude those who do not agree to be audio recoded.   
 
Recruitment 
 
We will recruit participants primarily via WAST’s contacts with cardiac arrest survivor 
and bystander groups. Members of the research team also have extensive contacts 
and/or direct involvement with Resuscitation Council UK, British Heart Foundation, 
other local ambulance services and a national group called Sudden Cardiac Arrest 
UK. All have links with people who have sustained an out-of-hospital cardiac arrest 
and those who were involved in helping them at the time.  
 
We will ask these organisations to send out a brief explanation of the project via email 
on our behalf, either as a standalone email or as part of a ‘newsletter’ or other regular 
update, according to their processes. We will also advertise the project using the 
institutional social media accounts of the research collaborators and the organisations 
mentioned above, according to each’s social media policies. The organisations 
mentioned have diverse memberships and we will liaise closely with our PPI co-
applicants to ensure that recruitment materials are accessible and relevant to all 
members of the communities that we serve.  
 
All recruitment advertisements will include contact details for the study team. For those 
that contact us and express a willingness to proceed, we will send out a study 
participant information sheet and consent form using SharePoint via Teams. A secure 
SharePoint/Teams link with access restrictions and permissions will be sent from a 
University of Warwick institutional email. We will confirm that they meet the eligibility 
criteria at this point. 
 
We will send one e-mail reminder to those who express an initial interest in the study 
but then do not follow-up one - two weeks after we have sent out the Participant 
Information Sheet and consent form. 
 

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We will ensure that participants have adequate time to consider their participation, ask 
questions (via email and/or telephone, depending on individual preference) and have 
them answered to their satisfaction. We will manage transfer and signing of consent 
forms using SharePoint via Teams by sharing links with appropriate access and 
permissions via email. Once we have completed the consent process we will arrange 
a mutually agreeable time to conduct a remote interview.  
 
We will use an encrypted audio-recorder to record interviews and, if available, use a 
second encrypted device to make a backup recording. We will transfer the recording(s) 
from the encrypted audio-recorder and, if available, second encrypted device to a 
folder on a secure server on University of Warwick-managed computers immediately 
after the interview. Once the audio-recording(s) have been transferred, we will 
securely delete the recording(s) from the encrypted audio-recorder(s). In addition, we 
will generate researcher fieldnotes after the interview to enrich data analysis. We will 
document contextual information (e.g. non-verbal communication behaviours) and 
share reflexive insights into how the interview went, including any notable discussion 
points and/or tentative themes emerging from the discussion. The fieldnotes will be 
linked to the participant's ID number and stored on a secure server on University of 
Warwick-managed computers. No participant-identifying information will be recorded 
in the researcher fieldnotes.  
 
The participants will have the option to have their camera on or off. At the start of each 
interview, we will confirm the participant’s identity and consent and check that the 
participant is happy to proceed.  
 
Participants will be able to pause, stop or postpone the interview at any point. They 
will be able to withdraw from the study at any time, and we will not keep information 
about them that we already have unless they withdraw after we have completed 
qualitative analyses and submitted them for publication or other output. If they 
withdraw before we have analysed their interview data, they can choose whether 
information collected in the interview up to that point is used or not. If they withdraw 
after we have analysed their data, we may not be able to identify exactly how 
information that came from one participant contributed to and influenced our overall 

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conclusions. This is because the ongoing, iterative nature of analysis and synthesis 
mean that once we code and analyse individual interviews those data and findings 
become an intricate part of the overall narrative. We may use direct, anonymised 
quotes in peer-reviewed articles or other research outputs. Participants who have 
withdrawn can request that direct quotes are not used – at any point up until articles 
have been accepted for publication. For other research outputs we will remove direct 
quotes if requested wherever we are able to do so (e.g. before printing of a conference 
poster, before submission of slides for an oral conference presentation). Participants 
will be offered a voucher to the value of £25, even if they do not complete the entire 
interview or subsequently withdraw their consent after the interview has finished.  
 
Sample size 
 
We plan to interview until we achieve data saturation, which we anticipate will require 
approximately twenty-four participants. We base this estimate on reviews of other 
studies using qualitative interviews (35) and our previous experience of interviewing 
people who have responded to out-of-hospital cardiac arrests (25). We may slightly 
increase the number of interviews if it becomes clear that we have not reached data 
saturation after 24 interviews (36). 
 
3.5 Analyses 
 
We will perform a framework analysis using the Theoretical Domains Framework 
(TDF) (37) to identify barriers and facilitators to drone-delivered AED use and to 
effective interaction with the 999 call-handler.  
 
We will group the 14 domains of the TDF so that we can characterise barriers and 
facilitators to effective use of a drone-delivered AED according to a bystander’s 
‘Capability’, ‘Opportunity’ and ‘Motivation’ – the so-called COM-B (Capability, 
Opportunity, Motivation – Behaviour) framework (38). We will then map the three core 
targets for behavioural change to identify potential interventions to enact this change 
using the Behaviour Change Wheel (39). 
 

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We have previous experience of using this sort of integrated model (25), and will adapt 
our approach here. 
 
We will use a University of Warwick approved commercial transcription service to 
transcribe interviews. We will upload audio that has been saved in a password-
protected folder on a secure server on University of Warwick-managed computers via 
the transcription company’s secure portal, and we will receive a transcription back from 
them via the same secure portal. Once transcription has been completed and we have 
checked its accuracy, we will securely delete the audio files from the secure university 
server. No participant-identifying information will form part of the transcription. 
The senior research fellow will be principally responsible for coding and keeping 
analytic memos during the analysis process to document their developing ideas and 
thoughts about the analysis, including ensuring that the information arising from the 
interviews can be sufficiently matched to the domains of the TDF for us to proceed 
with this framework. Coding will be done iteratively, with periodic checking with other 
members of the research team who have experience in this work (Dr Christopher 
Smith, Dr Keith Couper, Dr Nigel Rees). At the discretion of the senior research fellow, 
we may use a Computer Assisted Qualitative Data Analysis (CAQDAS) package to 
assist with data organisation and coding. 
 
3.6 Ethical and safety considerations 
 
This work package involves adult participants, presumed to have mental capacity to 
make decisions relevant to participation in this study, who have assisted (CPR +/- AED 
use) at real-world cardiac arrests. This is a potentially sensitive topic, and the 
participant information includes numbers for support agencies. This includes GP, NHS 
111 and telephone numbers and webpage contacts for MIND, Samaritans and Sudden 
Cardiac Arrest UK – the latter provides help and support to survivors and ‘co-survivors’ 
(people involved in a cardiac arrest) in the aftermath of the event.  The senior research 
fellow conducting the interviews will also follow a ‘Sensitive Call Action’ procedure 
developed by Warwick Clinical Trials Unit (CTU) (appendix 1). This outlines clear 
actions that the interviewer can take should there be an immediate concern for the 
wellbeing of the interview participant, and may include the researcher asking a senior 

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member of staff from the University for help and/or calling 999. Should this occur, the 
researcher will notify the participant first. These options are made clear to the 
participant in the Participant Information Sheet. Our PPI representatives have 
reviewed this information. 
 
In this work package, the risk to the interviewer is minimised by the remote nature of 
the interviews. However, this is still a sensitive topic. In the same way that the 
participant can, the senior research fellow can contact their GP, NHS 111 and access 
telephone numbers and webpage contacts listed in the Participant Information Sheet 
for MIND and Samaritans. They can also seek support from the University of Warwick's 
wellbeing services. 
 
We will keep a record of any adverse events of which we become aware. If there are 
any Serious Adverse Events related to the interview, then we will inform the sponsor 
within 24 hours of us becoming aware, in line with University of Warwick SOPs.  
 
We are interviewing people who responded in a ‘Good Samaritan’ role to an out-of-
hospital cardiac arrest. We will not provide any medical advice, including advice about 
the management of cardiac arrest. We will also emphasise at the start of the interview 
that we are not in any way making judgements about what happened during their own 
experience, rather we are seeking to understand how we might optimise the use of 
drone-delivered AEDs in the future.  
 
Remote interviewing, as well as being a pragmatic option, may result in a greater 
degree of actual or perceived anonymity (particularly with the option to turn cameras 
off). Additionally, when dealing with sensitive issues this may result in more honest or 
complete answers (41).  
 
 

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4. WORK PACKAGE 2 
 
4.1 Objectives 
 
Demonstrate capability for safe BVLOS flights of an AED-capable drone in controlled 
flight corridors. 
 
Create compatible systems between drone operator and ambulance service; optimise 
automated drone-activation systems and flight start-up procedures once out-of-
hospital cardiac arrest is identified during a 999 call.  
 
Demonstrate an AED drone-delivery system that is fully integrated with ambulance 
service systems, in ‘end-to-end’ (from 999 call to AED use on a patient) BVLOS flights 
for simulated out-of-hospital cardiac arrests.  
 
4.2 Development work 
 
Demonstrate capability for safe BVLOS flights of an AED-capable drone in controlled 
flight corridors. 
 
We 
have 
partnered 
with 
a 
UK 
drone 
company, 
SkyBound 
Rescuer 
(https://SkyBoundrescuerproject.com/), who specialise in using automated drones for 
public safety.  
 
SkyBound have developed a comprehensive Operational Safety Case that details the 
testing of an AED-capable drone in BVLOS flight using dedicated air corridors. We will  
liaise with and receive all necessary approvals from the UK Civil Aviation Authority 
(CAA) to perform the drone flight required in this work package. 
 
Create compatible systems between drone operator and ambulance service; optimise 
automated drone-activation systems and flight start-up procedures once out-of-
hospital cardiac arrest is identified.  
 

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SkyBound and WAST have agreed a plan of work to integrate automated remote drone 
activation procedures with their Emergency Operations Centre, and to provide 
appropriate training in these procedures. Once an out-of-hospital cardiac arrest is 
identified during a 999 call and a request has been made to SkyBound’s software, the 
drone can launch instantaneously and automatically. SkyBound and WAST will also 
develop communication procedures between drone operator and the Emergency 
Operations Centre during drone flight, thus providing the 999 call-handler with real-
time information about the drone and its location that they can relay to the bystander 
at the scene of a cardiac arrest.  
 
4.3 Approach and rationale 
 
Demonstrate an AED drone-delivery system that is fully integrated with ambulance 
service systems, in ‘end-to-end’ BVLOS flights for simulated out-of-hospital cardiac 
arrests.  
 
We have previously demonstrated that study participants can interact with a drone-
delivered AED (19). What has not been tested before in the UK is a fully-integrated 
system that allows the BVLOS delivery of an AED via drone following diagnosis of 
cardiac arrest during a 999 call. 
 
In this work package, we will ask study participants to come to the aid of simulated 
out-of-hospital cardiac arrest patients and to call ‘999’. The call will be directed to a 
WAST training call centre, which operates in the same way as a real 999 call, and 
used by us in our previous simulation study (19). In all other regards, the processes 
demonstrated in this work package (cardiac arrest diagnosis, automated drone 
activation, drone flight, real-time communications between drone and Emergency 
Operations Centre, AED delivery) will occur as they would in a real-world scenario. 
 
When delivering an AED via drone, one important consideration is how long it takes a 
bystander to retrieve and attach the AED. Unnecessary delays in performing CPR can 
be detrimental to patient outcome, but potential delays caused by retrieving and using 
an AED must be balanced against the potential benefits of early defibrillation. Not all 

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patients in cardiac arrest will be suitable for defibrillation. It is not possible to know this 
in advance – an AED performs heart rhythm analysis and then shocks / does not shock 
according to its findings. Knowing how quickly a shock can be delivered and how long 
a bystander has to spend away from a patient to retrieve an AED will be an important 
consideration when implementing effective drone-delivered AED systems in the future. 
 
Our previous simulation study demonstrated the importance of the bystander / 999 
call-handler interaction in the process of retrieving and using a drone-delivered AED. 
This study will use information from audio/video analyses and from conversations to 
help ambulance services determine how best to communicate information about the 
arriving drone, and how best to offer advice during the 999 call about using an AED 
effectively. 
 
Successful completion of this work package is one of the necessary pre-requisites for 
testing drone-delivery of AEDs for real-world out-of-hospital cardiac arrest. Other work 
is necessary too, such as modelling optimal locations for AED-capable drone sites so 
that a drone-delivered AED can reach a high proportion of patients in a suitable time-
frame. Such modelling work is beyond the scope of this project but is planned for future 
work. It is feasible and has been conducted in other countries (9, 13, 42). 
 
4.4 Study design 
 
This will be an end-to-end test of drone-delivery of AEDs for simulated out-of-hospital 
cardiac arrest. 
 
A study participant will find an adult ‘patient’ (a resuscitation manikin) in an outdoor 
location. They will be instructed only that: the person has collapsed in front of them 
and is not breathing and that they should call ‘999’. We will provide participants with a 
mobile phone with a pre-programmed number to make this call. The 999 call will 
connect to a WAST call-handler at a training centre. 
 
The call-handler will handle it as a real-world call, asking questions, diagnosing cardiac 
arrest and providing telephone CPR instructions according to existing protocols. Once 

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cardiac arrest has been diagnosed during the 999 call, an automated instruction will 
be sent to a remote-located drone. This will start up, determine an appropriate flight-
path and fly an AED to the cardiac arrest location. The drone pilot and 999 call-handler 
will have a ‘live’ line of communication during the flight.  
 
The call-handler will inform participants that they have dispatched an AED via drone 
and update them when the drone’s arrival is imminent. The drone will hover at the 
target location and lower the AED to the ground via winch. Video-recording equipment 
is integral to the drone and the drone operator can review in real-time that it is safe 
and appropriate to lower the AED to the ground. The winch will retract and the drone 
will hover above the AED to help indicate its location. The drone operator will indicate 
to the call-handler that it is safe to approach the drone, and the call-handler will relay 
this information to the participant. Once the participant has retrieved the AED the drone 
will start its flight back to its start location. The participant will then attach the AED to 
the patient. The AED will prompt them to deliver a single shock to the patient and the 
scenario will end.   
 
The drone system will integrate with a commercial Unified Traffic Management (UTM) 
system (Guardian UTM) to simulate delays caused by receiving necessary BVLOS 
permission from the Civil Aviation Authority that would occur in unrestricted real-world 
flights outside of the designated corridor used for this study.  
 
We can feasibly run six end-to-end scenarios per day. Each flight session (one day) 
will have received Civil Aviation Authority approval and will have a specific operational 
risk assessment prepared by SkyBound and the study team. We will rectify critical 
issues identified from participant feedback and by audio/video review after each flight 
session. Experience from our commercial partners suggests that for development of 
a system like this we will need up to four flying sessions, with critical issues identified 
in one session rectified before the next. 
 
4.5 Participants and recruitment 
 
We will recruit adults (> 18 years old) who: 

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 have mental capacity to make decisions about study participation. 
 believe themselves to have the physical and mental capability to perform CPR 
and use an AED in an outdoor environment. 
 believe themselves able to use a mobile phone to communicate with a 999 call-
handler. 
  
We will exclude participants who are or who believe themselves to be pregnant, or 
those that are unable to complete the simulation because of physical or psychological 
distress.  
 
Recruitment 
 
We will recruit participants primarily by advertising via our contacts with WAST. We will 
seek the assistance of other groups such as Resuscitation Council UK and British 
Heart Foundation if necessary. We will also liaise with and advertise to local (to the 
simulation location) CPR training groups (e.g. St John, HeartStart) and other 
interested community groups. We will ask these organisations to send out a brief 
explanation of the project via email on our behalf, either as a standalone email or as 
part of a ‘newsletter’ or other regular update, according to their processes. We will also 
advertise the project using the institutional social media accounts of the research 
collaborators and the organisations mentioned above, according to each’s social 
media policies. The organisations mentioned have diverse memberships and we will 
liaise closely with our PPI co-applicants to ensure that recruitment materials are 
accessible and relevant to all members of the communities that we serve.  
 
We will look to recruit some participants who have had CPR/AED training (+/- have 
real-world experience of performing CPR and/or using an AED) and some who have 
not. A 2017 survey of UK adults showed that 40% of the adult population had not been 
trained in CPR, and 80% had not been trained in AED use (43). If, during the 
recruitment process, we note that we are disproportionately recruiting either trained or 
untrained participants, we will adjust our advertisement process so that we 
subsequently recruit only from the under-represented group.  
 

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All recruitment advertisements will include contact details for the study team. For those 
who contact us and express a willingness to proceed, we will send out a study 
participant information sheet and consent form using SharePoint via Teams. A secure 
SharePoint/Teams link with access restrictions and permissions will be sent from a 
University of Warwick institutional email in order that potential participants can 
familiarise themselves with the study details and the statements on the consent form. 
Correspondence via SharePoint/Teams will include information on the date/time and 
exact location of the study. We will confirm that they meet the eligibility criteria at this 
point.  
 
We will send one e-mail reminder to those who express an initial interest in the study 
but then do not follow-up one - two weeks after we have sent out the Participant 
Information Sheet and consent form. 
 
We will ensure that participants have adequate time to consider participation, ask 
questions and have them answered to their satisfaction, and to complete the consent 
form. On the study day itself we will re-confirm eligibility, answer any further questions 
and obtain written consent. We will then proceed with the simulation.  
 
We anticipate that simulations will take up to 30 minutes to complete. We will ask 
people to arrive 30 minutes before the start of the simulation, and the post-simulation 
questionnaire and conversation will take no more than 15 minutes. Even allowing for 
delays, participants will spend a maximum of 90 minutes at the simulation site – it may 
well be far less. We refer to our previous drone simulation study experience when 
making these estimates (19). Participants will be able to stop the simulation at any 
point if they feel unable to continue. We will have a live communication channel to the 
drone pilot to inform them if this happens before the drone arrives so that the drone 
pilot can recall the drone to its base.  
 
Participants will be able to withdraw from the study at any time. If they withdraw after 
we have analysed their post-event conversations and audio/video files associated with 
a particular simulation, we may not be able to identify exactly how all information that 
came from one participant contributed to and influenced our overall conclusions. We 

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will not keep information about them that we already have unless they withdraw after 
we have completed quantitative analyses and submitted them for publication or other 
output. We will securely delete audio and video recordings once we have completed 
and documented our analysis of them. Participants will be offered a voucher to the 
value of £25, even if they do not complete the simulation or subsequently withdraw 
their consent after the simulation has finished.  
 
Sample size 
 
In our previous simulation study we recruited 18 participants without difficulty and 
gathered a wealth of information about how processes surrounding AED delivery by 
drone might be optimised (19). Given this and the daily maximum limit on flights, we 
have set an a priori sample size of 20 participants here. 
 
4.6 Outcomes 
 
Clinical timings 
 
Members of the study team will be present during simulations and will manually record 
this at the simulated out-of-hospital cardiac arrest site, and confirm the timings 
following analysis of video recordings: 
 
 
Total time from 999-call to AED application (and to first shock). 
 
Time away from the patient’s side. 
 
Hands off CPR time. 
 
Hands-off CPR time is the time between stopping chest compressions and 
recommencing chest compressions when attaching and using an AED. ‘Time away 
from patient’s side’ allows us to quantify the additional hands-off CPR time caused by 
leaving the patient to retrieve the AED that the drone has delivered nearby.  
 
Drone timings 
 

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The study team will record these following analysis of 999 call audio and drone-
mounted video, supplemented by manual recordings by the study team at the 
simulated out-of-hospital cardiac arrest site: 
 
 
Time from 999-call to ‘ready for flight’ and ‘start of flight’ (following Guardian 
UTM approvals). 
 
Total flight time. 
 
Time from arrival on scene to AED safe to retrieve and to AED attached to 
patient. 
 
Additional information 
 
We will collect participant feedback immediately following the end of the simulation, 
using the approach from our previous simulation study (19): 
 
 
Questionnaire, based on the ‘System Usability Scale’, developed to evaluate 
usability of new devices or systems (44) (appendix 2). 
 
Brief (<5 minute) conversation. We will ask about age, gender and previous 
CPR/defibrillator training and real-world experience. We will ask them their 
thoughts about the simulation, using a style from resuscitation courses 
evaluating behaviours during mock cardiac arrests (45) (appendix 3). 
 
4.7 Analyses 
 
We will report timings and score from the questionnaire based on the System Usability 
Scale using median and interquartile range.  
 
The study team will review other data collected during the study itself: 
 
 
Audio recordings of 999-calls and voice/text interactions between drone pilot 
and 999 call-handler. 
 
Video from the drone itself during flight. 
 
Video from the scene of participant interaction with drone and AED. 

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 
Feedback from 999-call-handler and drone operator. 
 
Real-time observations and field-notes about the out-of-hospital cardiac arrest 
simulations. 
 
We will review participant feedback and on-site observations after each flight 
session to identify any critical issues before subsequent sessions. We will collate the 
summated information following the simulation to identify key themes related to: drone 
activation process, real-time in-flight communications between drone and ambulance 
service, and interaction between bystander and drone. Our aim is to iteratively improve 
the integrated drone-dispatch process throughout the study period, and in preparation 
for future flight operations for real-life out-of-hospital cardiac arrests. 
 
4.8 Ethical and safety considerations 
 
We are conducting simulated cardiac arrest scenarios, but this may be a sensitive 
topic for some bystanders (for example, if they have real-life experience of finding a 
collapsed casualty). The Participant Information Sheet includes information about 
sources of help for any participant who experiences distress. Our PPI representatives 
have reviewed this information. 
 
During the simulation itself a participant can stop at any time if they experience 
distress, and a member of the research team will be immediately on hand to stop the 
simulation or provide support if required.  
 
We will keep a record of any adverse events of which we become aware. If there are 
any Serious Adverse Events related to the simulation, then we will inform the sponsor 
within 24 hours of us becoming aware. Should this happen, we will approach the 
Warwick CTU Quality Assurance team for the appropriate template to submit the 
report.  
 
Drone flight will take place in a pre-determined flight corridor and be subject to 
approval from the CAA, following the submission and approval of a detailed Operating 
Safety Case. The development work allows for 45 days of flying and development work 

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before the start of this work package – this has been fully costed and resources and 
time have been appropriately allocated for this.  
 
The Guardian UTM system deconflicts our drone flight with manned and unmanned 
traffic, by redirecting or grounding other aircrafts or by rejecting or altering the flight 
plan. SkyBound's automated drone station also has technology to monitor manned 
and unmanned aircrafts within the airspace. These technologies will automate the 
BVLOS permission activities required to get airborne and allow the drone to respond 
as quickly as possible.  
 
Flights will be conducted by an experienced and fully-trained drone pilot employed by 
SkyBound. We will control access to the simulation study site so that there are no 
‘uninvolved’ personnel present at the site where the drone will lower the AED (i.e. only 
study personnel and the study participant for that particular simulation will be present). 
 
 
 

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5. DATA MANAGEMENT 
 
5.1 Data collection and management 
 
We will handle and store personal data collected during the study in accordance with 
the UK GDPR, adhering to the University of Warwick’s Data Protection Policy and 
Information Classification and Handling Procedures, and University of Warwick SOP 
15 on Information Handling and Electronic Data Security. 
 
All data in work package 1 will be collected in electronic format: e-mailed signed 
consent forms, interview recordings, transcripts, researcher fieldnotes, CAQDAS files.  
 
For work package 2 there will be some data collected at the study site initially on paper 
– signed consent forms, post-event conversation notes, post-event questionnaire. As 
soon as is reasonably practicable, we will return paper-based documents completed 
at the study site to the University of Warwick, where they will be saved in electronic 
format. We will arrange secure transfer of audio and video files recorded during the 
simulation to an encrypted, password-protected folder on a University of Warwick 
managed device as soon as is practicable following the simulation, and certainly within 
48 hours.  
 
WAST will provide Dr Christopher Smith with a link to a secure server to access audio 
recordings of the 999 calls. Dr Christopher Smith will access this server at the 
University of Warwick and transfer the recordings directly to an encrypted password-
protected folder (Symantec PGP encryption) on a secure University of Warwick file 
server. 
 
There will be video recordings from the drone itself during flight (recorded by 
SkyBound) and at the simulation site (using a commercial service). These, similarly, 
will be made available to Dr Christopher Smith to access via secure server and to 
transfer directly to an encrypted password-protected folder (Symantec PGP 
encryption) on a secure University of Warwick file server. Any original video files 
showing participants will be deleted as soon as this transfer has been made. 

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5.2 Data storage 
 
We will keep all data in an encrypted, password-protected folder (Symantec PGP 
encryption) on a secure University of Warwick file server. 
 
We will store electronic consent forms separately to all other participant documents, 
in a password-protected subfolder. These will have a numbering system that allows 
them to be matched to other participant documents in other subfolders, should this be 
needed. All other participant-related documents will have a number only. 
 
5.3 Data access and quality assurance 
 
Only Dr Christopher Smith, Dr Keith Couper, the senior research fellow and the 
statistician directly employed to this project will directly access study documents in the 
encrypted folder. They will only be able to access the study folder after logging in to 
their University of Warwick accounts via University-managed computers. We will 
encrypt the study folder using (Symantec PGP Encryption) 
 
If study team members are accessing the folder off-campus, they will first have to have 
connected to the University’s Virtual Private Network.  
 
5.4 Data shared with third parties 
 
We will send an audio recording to an outside commercial transcription service via 
their secure portal, and we will receive a transcription back from them via the same 
secure portal. No participant-identifying information will form part of the transcription. 
We may share fully anonymised data with other members of the study team not 
primarily based at the University of Warwick for the purposes of quality assurance and 
review. We may make fully-anonymised datasets available as part of any peer-
reviewed publication, according to the requirements of that journal. We will not share 
any data with any other third party. We will not share individual case data or any 
personal identifiable data at any time. 
 

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5.5 Archiving 
 
We will hold personal identifiable information, including the names, email addresses 
and/or phone numbers of participants until the end of the study. We will hold personal 
data on consent forms only until the peer-reviewed scientific articles are published, in 
case a participant wishes to withdraw their consent. We anticipate that this will be a 
maximum of 12 months after the end of the study, and we will securely delete this 
personal data earlier if possible. All personal identifiable data will be securely stored 
in a password protected folder on the University of Warwick server and accessed only 
by authorised study personnel. We will retain all other study data on the University of 
Warwick server for at least ten years from the date of any publication based upon this 
study, in line with the University’s Research Data Management Policy:  
 
https://warwick.ac.uk/services/ris/research_integrity/code_of_practice_and_policies/r
esearch_code_of_practice/datacollection_retention/research_data_mgt_policy  
 
Only Dr Christopher Smith will have access to this data, if required, after peer-
reviewed publication. He will be responsible for its storage and eventual deletion. 
Encryption programmes provided by the University can securely remove this data and 
we will seek advice from IT Services about the best way to do this at that time.

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6. STUDY ORGANISATION 
 
6.1 Sponsorship arrangements 
 
The University of Warwick will sponsor this project. 
 
6.2 Collaborators 
 
This project is a collaboration between the University Hospitals Coventry and 
Warwickshire NHS Trust, University of Warwick, Welsh Ambulance Service NHS Trust 
and SkyBound Rescuer. 
 
6.3 Patient and public involvement 
 
We have two PPI representatives in this project. They will be active members of the 
research team, participating in group meetings and communications. Their time and 
efforts are fully costed. They will have an important role in reviewing all aspects of the 
project where we interact or share information with participants. 
 
In particular, they have reviewed this protocol document and all review patient-facing 
documents (participant information leaflets, consent documents). They will be present 
at the cardiac arrest simulations (work package 2) to help with study participants and 
to provide real-time feedback on our study processes. They will contribute to (and co-
author) peer-reviewed publications and all other outputs from the project. 
 
Mark Holt resuscitated his own father in an isolated location but, thankfully, there was 
an AED at the site. He successfully defibrillated his father (after using an AED for the 
very first time), who was conscious by the time the ambulance arrived. He survived 
with no brain injury. Mark works as a Registered Nursing Associate in the NHS. He 
therefore has seen and participated in unsuccessful resuscitation attempts and knows 
how devastating this can be. He has a keen interest in making AEDs more equitably 
available to the population. 
 

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Mary O’Sullivan works as a data manager. She has experience of working on 
commercial and academic research projects, but not in the field of cardiac arrest. She 
has no experience of performing CPR or using an AED. She partnered successfully 
with us as a PPI member during our previous simulation work (19) and we are 
delighted that she has chosen to join us for the next phase of our work. She is an ideal 
person to provide technical input to project documents whilst retaining a crucial 
perspective as an untrained bystander: she will ensure that project materials are clear 
and precise for participants and that we do not overly burden them in both interviews 
(work package 1) and simulated out-of-hospital cardiac arrests (work package 2). 
 
6.4 Ethical and regulatory approvals 
 
We are seeking NHS Research Ethics Committee (REC) and Health Research 
Authority (HRA) approvals for this project, and this protocol accompanies an 
Integrated Research Application System (IRAS) application.  
 
Interview participants (work package 1) are NHS service users, being recruited 
because they intervened at an out-of-hospital cardiac arrest and likely interacted with 
an NHS ambulance service on a 999 call and/or at the scene. No flying will take place 
without permissions from the CAA. 
 
6.5 Indemnity and insurance 
 
NHS indemnity covers NHS staff, medical academic staff with honorary contracts, and 
those conducting the trial. NHS bodies carry this risk themselves or spread it through 
the Clinical Negligence Scheme for Trusts, which provides unlimited cover for this risk.  
The University of Warwick provides indemnity for any harm caused to participants by 
the design of the research. 
 
Drone-specific issues 
 

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SkyBound Rescuer has operational authorisations from the UK CAA to fly unmanned 
aircraft, with a flying weight of less than 25kg. SkyBound Rescuer will provide drone 
pilot(s), who will be fully licensed and accredited.  
 
SkyBound Rescuer has Public Liability Insurance (worldwide) for up to £10 million for 
the duration of this project. An Operational Safety Case detailing all activities in this 
project has been submitted to the CAA, and no flying will take place without their 
express approvals.  
 
The drone has two cameras. The first is a ‘First Person View’ camera that is always 
forwards facing and so cannot identify people or personal information on the ground. 
The second is downward facing and allows the drone operator to see that the lowering 
zone is clear of people and obstructions. The camera resolution is such that individual 
people and personal information (e.g. number plates, house numbers) are not 
identifiable.  
 
6.6 Study timeline 
 
This project is funded for 18 months. Appendix 4 shows a GANTT chart detailing the 
study timeline.  
 
6.7 Administration 
 
The NIHR have issued a research contract to University Hospitals Coventry and 
Warwickshire (UHCW) NHS Trust, who have arranged collaboration agreements with 
WAST and with University of Warwick. The University of Warwick have administered 
the relevant commercial subcontract with SkyBound Rescuer. 
 
6.8 Funding 
 
This project has received funding from Competition 47 of the NIHR RfPB scheme (ref: 
NIHR204382). We will also receive funding for Excess Treatment Costs from Health 
and Care Research Wales (HCRW). 

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6.9 Essential documentation 
 
We will store all study material in an encrypted, password-protected folder on secure 
servers at the University of Warwick in line with the University of Warwick SOP 11 
(Essential Documentation: Creation and Maintenance of Trial Master and Investigator 
Site Files), and with advice from the Quality Assurance Team at Warwick Clinical Trials 
Unit. 
 
6.10 Intellectual Property 
 
The project will be using and testing SkyBound Rescuer’s background IP, as outlined 
in this table: 
 
Description of Background IP 
Owner 
Nature 
of 
Restriction 
Risk to Research & 
Outcomes 
SkyBound Coordinator platform: software 
platform that manages the end-to-end 
process of data-driven public safety drone 
missions 
SkyBound 
Rescuer 
Nil 
Nil 
SkyBound Requestor platform: software 
portal to request a drone mission 
SkyBound 
Rescuer 
Nil 
Nil 
SkyBound Remote Viewer Portal: portal for 
remote viewers to monitor the drone's feed 
and location and interact with the live feed 
SkyBound 
Rescuer 
Nil 
Nil 
SkyBound Manager platform: software 
platform that catalogues/manages ground 
risks, air risks, installation, and maintenance 
for a drone network 
SkyBound 
Rescuer 
Nil 
Nil 
Training standards & materials for using 
each SkyBound platform 
SkyBound 
Rescuer 
Nil 
Nil 
5-Phase BVLOS methodology: a step by 
step 
process 
for 
achieving 
BVLOS 
permission from the CAA 
SkyBound 
Rescuer 
Nil 
Nil 
Mission planning algorithm for drone defib 
deliveries, 
inc. 
flight 
parameters 
& 
configuration details produced by SBR 
research 
SkyBound 
Rescuer 
Nil 
Nil 
Design spec for an automated drone defib 
delivery system 
SkyBound 
Rescuer 
Nil 
Nil 
CONOPs and Operations Manuals for public 
safety drone applications 
SkyBound 
Rescuer 
Nil 
Nil 
 

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Foreground IP is owned by the Contractor except for: the Operational Safety Case for 
Beyond Visual Line of Sight which will be owned by SkyBound Innovations Ltd. 
 
Research Data is owned or controlled by the Contractor. The contractor will put into 
place data sharing arrangements as necessary so that relevant Foreground IP arising 
as a result of this project can be used by collaborators for the purposes of 
dissemination, education and as a basis for future related research. 
 
 
 

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7. DISSEMINATION AND IMPACT 
 
Our audiences are patients and the public, clinicians, and policy makers (including 
NHS and UK ambulance service leaders). We will involve all study team members, 
including our PPI members, to: 
 
 
produce written summaries and infographics for both lay and professional 
audiences 
 
Disseminate our findings via open-access peer-reviewed publications (one for 
the findings of each work package), podcasts, blogs, national and international 
conference presentations and social media 
 
Use public relations teams from the University of Warwick, WAST, regulatory 
agencies and SkyBound to assist in dissemination of our findings according to 
their current procedures 
 
Engage policy makers through our existing relationships with key organisations 
(e.g. 
International 
Liaison 
Committee 
on 
Resuscitation, 
European 
Resuscitation Council, Resuscitation Council UK, British Heart Foundation). 
 
 
 
 
 

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8. REFERENCES 
 
1. 
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2. 
Yan S, Gan Y, Jiang N, Wang R, Chen Y, Luo Z, et al. The global survival rate among adult out-of-
hospital cardiac arrest patients who received cardiopulmonary resuscitation: a systematic review 
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3. 
OHCAO Registry. (Jan 2023). Out-of-Hospital Cardiac Arrest Overview: English Ambulance 
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Blom MT, Beesems SG, Homma PCM, Zijlstra JA, Hulleman M, van Hoeijen DA, et al. Improved 
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6. 
Brown TP, Booth S, Hawkes CA, Soar J, Mark J, Mapstone J, et al. Characteristics of 
neighbourhoods with high incidence of out-of-hospital cardiac arrest and low bystander 
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7. 
Holmberg MJ, Vognsen M, Andersen MS, Donnino MW, Andersen LW. Bystander automated 
external defibrillator use and clinical outcomes after out-of-hospital cardiac arrest: A systematic 
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8. 
Bækgaard JS, Viereck S, Møller TP, Ersbøll AK, Lippert F, Folke F. The Effects of Public Access 
Defibrillation on Survival After Out-of-Hospital Cardiac Arrest: A Systematic Review of 
Observational Studies. Circulation. 2017;136(10):954-65. 
9. 
Boutilier J, Brooks S, Janmohamed A, Byers A, Buick J, Zhan C, et al. Optimizing a Drone Network 
to Deliver Automated External Defibrillators. Circulation. 2017;135:2454-65. 
10. Cheskes S, McLeod SL, Nolan M, Snobelen P, Vaillancourt C, Brooks SC, et al. Improving Access 
to Automated External Defibrillators in Rural and Remote Settings: A Drone Delivery Feasibility 
Study. J Am Heart Assoc. 2020;9(14):e016687. 
11. Claesson A, Fredman D, Svensson L, Ringh M, Hollenberg J, Nordberg P, et al. Unmanned aerial 
vehicles (drones) in out- of-hospital-cardiac-arrest. Scand J Trauma Resusc Emerg Med. 
2016;24:124. 
12. Carolina Baumgarten M, Röper J, Hahnenkamp K, Thies KC. Drones Delivering Automated 
External Defibrillators-Integrating Unmanned Aerial Systems into the Chain of Survival: A 
Simulation Study in Rural Germany. Resuscitation. 2022;172:139-45. 
13. Pulver A, Wei R, Mann C. Locating AED Enabled Medical Drones to Enhance Cardiac Arrest 
Response Times. Prehosp Emerg Care. 2016;20:378-89. 
14. Claesson A, Bäckman A, Ringh M, Svensson L, Nordberg P, Djärv T, et al. Time to Delivery of an 
Automated External Defibrillator Using a Drone for Simulated Out-of-Hospital Cardiac Arrests vs 
Emergency Medical Services. JAMA. 2017;317:2332-4. 
15. Schierbeck S, Hollenberg J, Nord A, Svensson L, Nordberg P, Ringh M, et al. Automated external 
defibrillators delivered by drones to patients with suspected out-of-hospital cardiac arrest. Eur 
Heart J. 2022;43:1478-87. 
16. Schierbeck S, Svensson L, Claesson A. Use of a Drone-Delivered Automated External Defibrillator 
in an Out-of-Hospital Cardiac Arrest. N Engl J Med. 2022;386(20):1953-4. 
17. Sanfridsson J, Sparrevik J, Hollenberg J, Nordberg P, Djärv T, Ringh M, et al. Drone delivery of an 
automated external defibrillator – a mixed method simulation study of bystander experience. Scand 
J Trauma Resusc Emerg Med. 2019;27:40. 
18. Zègre-Hemsey JK, Grewe ME, Johnson AM, Arnold E, Cunningham CJ, Bogle BM, et al. Delivery 
of Automated External Defibrillators via Drones in Simulated Cardiac Arrest: Users' Experiences 
and the Human-Drone Interaction. Resuscitation. 2020;157:83-8. 
19. Smith CM, Sheehan A, Rees N, Powell C. Drone delivered defibrillators (The 3D Project): a 
simulation study. Emerg Med J. 2022;39:258. 

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20. Rees N, Howitt J, Breyley N, Geoghegan P, Powel C. A simulation study of drone delivery of 
Automated External Defibrillator (AED) in Out of Hospital Cardiac Arrest (OHCA) in the UK. PLoS 
One. 2021;16(11):e0259555. 
21. NHS. 
(January 
2019). 
The 
NHS 
Long 
Term 
Plan. 
Available 
from: 
https://www.longtermplan.nhs.uk/wp-content/uploads/2019/01/nhs-long-term-plan.pdf 
[last 
accessed 4th February 2019]. 
22. Brown TP, Perkins GD, Smith CM, Deakin CD, Fothergill R. Are there disparities in the location of 
automated external defibrillators in England? Resuscitation. 2022;170:28-35. 
23. Smith CM, Lim Choi Keung SN, Khan MO, Arvanitis TN, Fothergill R, Hartley-Sharpe C, et al. 
Barriers and facilitators to public access 
defibrillation in out-of-hospital cardiac arrest: 
a 
systematic review. Eur Heart J Qual Care Clin Outcomes. 2017;3:264-73. 
24. Brooks B, Chan S, Lander P, Adamson R, Hodgetts GA, Deakin CD. Public knowledge and 
confidence in the use of public access defibrillation. Heart. 2015;101(12):967-71. 
25. Smith CM, Griffiths F, Fothergill RD, Vlaev I, Perkins GD. Identifying and overcoming barriers to 
Automated External Defibrillator use by GoodSAM volunteer first-responders in out-of-hospital 
cardiac arrest using the Theoretical Domains Framework and Behaviour Change Wheel. A 
qualitative study. BMJ Open. 2020;10:e034908. 
26. Sondergaard KB, Hansen SM, Pallisgaard JL, Gerds TA, Wissenberg M, Karlsson L, et al. Out-of-
Hospital Cardiac Arrest: Probability of Bystander Defibrillation relative to Distance to Nearest 
Automated External Defibrillator. Resuscitation. 2018;124:138-44. 
27. Haywood K, Whitehead L, Nadkarni VM, Achana F, Beesems S, Bottiger BW, et al. COSCA (Core 
Outcome Set for Cardiac Arrest) in Adults: An Advisory Statement From the International Liaison 
Committee on Resuscitation. Resuscitation. 2018;127:147-63. 
28. Dainty KN, Seaton MB, Cowan K, Laupacis A, Dorian P, Douma M, et al. Partnering with survivors 
& families to determine research priorities for adult out-of-hospital cardiac arrest: A James Lind 
Alliance Priority Setting Partnership. Resusc Plus. 2021;7:100148. 
29. Kragholm K, Wissenberg M, Mortensen RN, Hansen SM, Malta Hansen C, Thorsteinsson K, et al. 
Bystander Efforts and 1-Year Outcomes in Out-of-Hospital Cardiac Arrest. N Engl J Med. 
2017;376(18):1737-47. 
30. Riddersholm S, Kragholm K, Mortensen RN, Pape M, Hansen CM, Lippert FK, et al. Association 
of bystander interventions and hospital length of stay and admission to intensive care unit in out-
of-hospital cardiac arrest survivors. Resuscitation. 2017;119:99-106. 
31. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 
32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19:349-57. 
32. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, et al. 
Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: 
guidelines for reporting observational studies. BMJ. 2007;335(7624):806-8. 
33. Cheng A, Kessler D, Mackinnon R, Chang TP, Nadkarni VM, Hunt EA, et al. Reporting guidelines 
for health care simulation research: extensions to the CONSORT and STROBE statements. 
Advances in Simulation. 2016;1(1):25. 
34. Britten N. Qualitative Interviews. In: Pope C, Mays N, editors. Qualitative Research in Health Care. 
3rd ed. Oxford: Blackwell Publishing; 2006. p. 12-20. 
35. Mason M. Sample Size and Saturation in PhD Studies Using Qualitative Interviews. Forum: 
Qualitative Social Research. 2010;11(3). 
36. Francis JJ, Johnston M, Robertson C, Glidewell L, Entwistle V, Eccles MP, et al. What is an 
adequate sample size? Operationalising data saturation for theory-based interview studies. 
Psychology & health. 2010;25(10):1229-45. 
37. Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour 
change and implementation research. Implement Sci. 2012;7(1):37. 
38. Alexander KE, Brijnath B, Mazza D. Barriers and enablers to delivery of the Healthy Kids Check: 
an analysis informed by the Theoretical Domains Framework and COM-B model. Implement Sci. 
2014;9(1):60. 
39. Michie S, Atkins L, West R. The Behaviour Change Wheel: A Guide To Designing Interventions. 
London: Silverback Publishing; 2014. 
40. Michie S, Wood CE, Johnston M, Abraham C, Francis JJ, Hardeman W. Behaviour change 
techniques: the development and evaluation of a taxonomic method for reporting and describing 
behaviour change interventions (a suite of five studies involving consensus methods, randomised 
controlled trials and analysis of qualitative data). Health Technol Assess. 2015;19(99):1-188. 
41. King N, Horrocks C. Interviews in Qualitative Research. London: SAGE; 2010. 

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42. Schierbeck S, Nord A, Svensson L, Rawshani A, Hollenberg J, Ringh M, et al. National coverage 
of out-of-hospital cardiac arrests using automated external defibrillator-equipped drones - A 
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43. Hawkes CA, Brown TP, Booth S, Fothergill RT, Siriwardena N, Zakaria S, et al. Attitudes to 
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9. APPENDICES 
 
Appendix 1 – Sensitive Call Action flowchart 

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Appendix 2 – Post-event questionnaire (work package 2) 
 
PARTICIPANT NUMBER________ 
 
You have just retrieved a defibrillator delivered by a drone. Regarding this (please tick 
the relevant box): 
 
 
1. I found it unnecessarily complex. 
 
Strongly  
 
 
 
 
     Strongly  
 
 
 
disagree 
 
 
 
 
     agree 
 
 
 
 
 
 
1 
2 
3 
4 
5 
 
 
2. I thought it was easy to do. 
 
Strongly  
 
 
 
 
     Strongly  
 
 
 
disagree 
 
 
 
 
     agree 
 
 
 
 
 
 
1 
2 
3 
4 
5 
 
 
3. I felt very confident doing this. 
 
Strongly  
 
 
 
 
     Strongly  
 
 
 
disagree 
 
 
 
 
     agree 
 
 
 
 
 
 
1 
2 
3 
4 
5 
 
 
4. I would imagine that most people would be able to do this. 
 
Strongly  
 
 
 
 
     Strongly  
 
 
 
disagree 
 
 
 
 
     agree 
 
 
 
 
 
 
1 
2 
3 
4 
5 
 

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Appendix 3 – Post-event conversation questions (work package 2) 
 
PARTICIPANT NUMBER________ 
 
 
Age (in years) 
 
 
 
 
_________ 
 
Gender (M, F, identifies another way – specify) _________ 
 
Training in last five years (Yes/No) 
 
 
 
CPR only 
 
 
 
_________ 
 
 
 
AED only 
 
 
 
_________  
 
 
 
Both  
 
 
 
_________ 
 
Real-world experience in last five years (Yes/No, number of occasions if yes) 
 
 
 
CPR only 
 
 
 
_________ 
 
AED only 
 
 
 
_________  
 
Both  
 
 
 
_________ 
 
 
Opening question: 
 
 “What are your thoughts on how that went?” 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Probing questions (if needed): 
 
 “Did you encounter any difficulties in retrieving the defibrillator?” 
 
 
 
 
 
 
 
 
 
 
 
 
 
 “Is there something that would make it easier for you to retrieve the defibrillator” 
 
 
 
 
 
 
 
 
 
 
 
 
 
Closing question: 
 
 “Is there something else you would like to add to your answers so far?” 
 
 
 
 

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Appendix 4 – GANTT chart 
 
2023
2024
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Work Package 1
Protocol development and sponsorship
Ethics submission
Interview preparation / recruitment
Interviews
Transcription / data input
Data analysis
Data synthesis
Reporting and publication
Work Package 2
Protocol development and sponsorship
Ethics submission
Technical / development work
Recruitment
Flight days (x4)
Data capture and analysis
Reporting and publication