Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics (SATIATED): A Randomised Controlled Manikin Study
Conditions: Airway Management, Intubation, Intratracheal, Laryngoscopy, Vomiting
Sponsor: Yorkshire Ambulance Service NHS Trust

Soiled airway tracheal intubation and the 
effectiveness of decontamination by paramedics:   
A randomised controlled manikin study
The SATIATED Study
●
This protocol has regard for the HRA guidance and order of content
Version 1.0
25th May, 2018

RESEARCH REFERENCE NUMBERS
YASRD100
TRIAL REGISTRY NUMBER AND DATE
PROTOCOL VERSION NUMBER AND DATE
version 1.0, 25th May, 2018
SPONSOR / CO-SPONSORS / JOINT-SPONSORS
Yorkshire Ambulance Service NHS Trust
Springhill, Brindley Way
Wakefield 41 Business Park
Wakefield
WF2 0XQ
Tel: 0845 124 1241
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FULL/LONG TITLE OF THE TRIAL
Soiled airway tracheal intubation and the effectiveness of decontamination by paramedics: A 
randomised controlled manikin study
SHORT TRIAL TITLE / ACRONYM
The SATIATED study
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RESEARCH REFERENCE NUMBERS
IRAS Number:
245954
Clinical trials.gov Number:
SPONSORS Number:
YASRD100
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KEY TRIAL CONTACTS
Chief Investigator
Richard Pilbery
Trust Headquarters
Yorkshire Ambulance Service NHS Trust
Springhill, Brindley Way
Wakefield 41 Business Park
Wakefield
WF2 0XQ
Email: r.pilbery@nhs.net
Tel: 07768 926363
Sponsor
Yorkshire Ambulance Service NHS Trust
Springhill, Brindley Way
Wakefield 41 Business Park
Wakefield
WF2 0XQ
Tel: 0845 124 1241
Funder(s)
College of Paramedics
The Exchange
Express Park
Bristol Road
Bridgwater
TA6 4RR
Statistician
Dr. M. Dawn Teare
Design, Trials & Statistics
School of Health and Related Research (ScHARR)
University of Sheffield
Regent Court, 30 Regent Street
Sheffield S1 4DA
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i. LIST of CONTENTS
FULL/LONG TITLE OF THE TRIAL
3
SHORT TRIAL TITLE / ACRONYM
3
RESEARCH REFERENCE NUMBERS
4
KEY TRIAL CONTACTS
5
i. LIST of CONTENTS
6
ii. LIST OF ABBREVIATIONS
8
iii. TRIAL SUMMARY
9
iv. FUNDING AND SUPPORT IN KIND
9
v. ROLE OF TRIAL SPONSOR AND FUNDER, TRIAL MANAGEMENT COMMITTEES
10
vi. Protocol contributors
10
vii. KEY WORDS:
10
viii. TRIAL FLOW CHART
11
1
BACKGROUND AND RATIONALE
12
1.1
Assessment and management of risk
13
2
AIMS, OBJECTIVES AND OUTCOMES
13
2.1 Aim and research question
13
2.2. Primary objective
14
2.3
Secondary objective
14
2.4
Primary endpoint/outcome
14
2.5
Secondary endpoints/outcomes
14
3
TRIAL DESIGN
14
4
TRIAL SETTING
14
5
PARTICIPANT ELIGIBILITY CRITERIA
15
5.1
Inclusion criteria
15
5.2
Exclusion criteria
15
6
TRIAL PROCEDURES
15
6.1
Recruitment
15
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6.2 Consent
15
6.3
Withdrawal criteria
16
7
INTERVENTION UNDER STUDY
16
7.1 SALAD manikin
16
7.2 Procedure
16
8
STATISTICS AND DATA ANALYSIS
18
8.1
Sample size calculation
18
8.2
Planned recruitment rate
19
8.3
Statistical analysis plan
19
8.3.1
Summary of baseline data and flow of patients
19
8.3.2
Primary outcome analysis
19
8.3.3
Secondary outcome analysis
19
8.4
Procedure(s) to account for missing or spurious data
19
9
DATA MANAGEMENT
20
9.1
Data collection tools and source document identification
20
9.2
Data handling and record keeping
20
9.3
Access to Data
20
9.4
Archiving
20
10
MONITORING, AUDIT & INSPECTION
21
11 
ETHICAL AND REGULATORY CONSIDERATIONS
21
11.1 
Research Ethics Committee (REC) review and reports
21
11.2 Peer review
21
11.3 Public and Patient Involvement
21
11.3 
Protocol compliance
21
11.4 
Data protection and participant confidentiality
22
11.5 
Financial and other competing interests for the chief investigator, PIs at each site and 
committee members for the overall trial management
22
11.6 
Indemnity
22
11.7 
Amendments
22
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11.8 
Access to the final trial dataset
22
12 
DISSEMINATION POLICY
23
12.1 
Dissemination policy
23
12.2 
Authorship eligibility guidelines and any intended use of professional writers
23
13
REFERENCES
23
14. 
APPENDICES
25
14.1
Appendix 1 – Amendment History
25
ii. LIST OF ABBREVIATIONS
AE
Adverse Event
AR
Adverse Reaction
CI
Chief Investigator
CRF
Case Report Form
DC
Direct current
GCP
Good Clinical Practice
HCPC
Health and Care Professions Council
ICF
Informed Consent Form
ICMJE
    The International Committee of Medical Journal Editors
NHS R&D
National Health Service Research & Development  
PIS
Participant Information Sheet
PPE
Personal Protective Equipment
PRA
Patient Research Ambassador
RCT
Randomised Controlled Trial
REC
Research Ethics Committee
SALAD
Suction Assisted Laryngoscopy and Decontamination
SDV
Source Data Verification
SOP
Standard Operating Procedure 
YAS
Yorkshire Ambulance Service NHS Trust
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iii. TRIAL SUMMARY
Trial Title
Soiled airway tracheal intubation and the effectiveness of 
decontamination by paramedics: A randomised controlled 
manikin trial
Internal ref. no. (or short title)
The SATIATED Study
Clinical Phase 
Not applicable 
Trial Design
Randomised controlled trial
Trial Participants
HCPC registered Paramedics employed by Yorkshire 
Ambulance Service NHS Trust
Planned Sample Size
154
Follow up duration
None
Planned Trial Period
1st July 2018 to 28th Feb 2019
Objectives
Outcome Measures
Primary
To determine the difference 
between paramedic first-pass 
intubation success, before 
and after SALAD training, in 
a simulated soiled airway
Difference in proportion of 
first-pass intubation success 
before and after SALAD 
training
Secondary
To determine the difference 
in time taken to achieve 
intubation success on the 
first-attempt, before and after 
SALAD training in a 
simulated soiled airway
Difference between mean 
time taken (in seconds) to 
perform a successful 
intubation on the first-
attempt, before and after 
SALAD training.
iv. FUNDING AND SUPPORT IN KIND
FUNDER(S)
FINANCIAL AND NON FINANCIALSUPPORT 
GIVEN
College of Paramedics Small Research Grant
£1250
v. ROLE OF TRIAL SPONSOR AND FUNDER, TRIAL 
MANAGEMENT COMMITTEES
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Yorkshire Ambulance Service NHS Trust (YAS) is the sponsor of this study as the employer of the 
Chief Investigator. Yorkshire Ambulance Service will undertake all sponsor responsibilities outlined the 
UK Policy Framework for Health and Social Care Research. 
The only condition of funding is that the funder, College of Paramedics, has requested a copy of the 
final study report. 
There will be no Trial management Committee for this study.
vi. Protocol contributors
Richard Pilbery and Mark Millins drafted the initial protocol. Expert input was provided by the 
anaesthetist who originally developed the SALAD concept, Dr. James DuCanto. Prof M. Dawn Teare 
provided statistical advice on sample sizing and analysis of results. A patient research ambassador 
(PRA) from YAS, Peter Webster, helped with plain English summaries and the dissemination strategy.
vii. KEY WORDS:
paramedic, airway management, suction assisted laryngoscopy and decontamination (SALAD), 
tracheal intubation
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viii. TRIAL FLOW CHART
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1
BACKGROUND AND RATIONALE
 
 
YAS has recently taken part in AIRWAYS-2, a randomised controlled trial, comparing the i-gel 
supraglottic airway device (SAD) versus tracheal intubation in the initial management of the airway in 
OHCA. This has provided an opportunity for closer scrutiny of advanced airway management by 
paramedics within the Trust, and has highlighted the challenge of intubation in the face of serious and/
or ongoing airway contamination by blood or vomit. Anecdotally, it appears that traditional suctioning 
and airway clearing techniques may be ineffective in this group of patients.
Vomiting and regurgitation are commonly encountered in out-hospital-cardiac arrest with a reported 
incidence of 20–30%.1,2 This is of concern since patients who have suffered an OHCA, are already in 
extremis. If standard suctioning techniques are not sufficient to maintain a clear airway and provide 
ventilation, then these patients will die, irrespective of the quality of chest compressions and the 
timeliness of defibrillation. Arguably, tracheal intubation is the preferred airway management technique 
in patients with ongoing airway contamination, but there is evidence that this is difficult to achieve 
when the airway is soiled.3 Even if patients survive to the hospital, it is possible that aspiration 
pneumonias may adversely affect survival outcome, although this has yet to be proved empirically.4
Traditional suctioning techniques have been criticised, and training in the management of 
contaminated airways, limited. This has led to the development of a combined suction/laryngoscopy 
technique to facilitate intubation, known as Suction Assisted Laryngoscopy and Airway 
Decontamination (SALAD), and the creation of modified airway manikins to allow for practice in these 
techniques.5
However, to date there has only been one study specifically looking at the SALAD technique and the 
outcomes were self-reported confidence measures of trainees in using the technique. Other 
techniques have been described to manage significant airway contamination, including the use of a 
meconium aspirator,6 which is not practical in the out-of-hospital environment (and requires a device 
that is not typically carried by UK ambulance services), and deliberate intubation of the oesophagus 
(the oesophageal diversion manoeuvre), of which the sum total of evidence in support of the 
procedure is a single case report.7
Prior to undertaking clinical studies, it is important to determine the feasibility of teaching the technique 
to paramedics in a brief training session, and testing whether it has a beneficial effect on paramedic 
intubation success. Training necessarily needs to be concise given the operational demands of the 
ambulance service at present, which is placing training time under increasing pressure. A training 
programme that required a whole day to undertake, for example, would not be pragmatic to 
implement.
In this study, the primary outcome measure of interest is first-pass intubation success. There are 
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published values on non-physician first-pass intubation success, which is reported to be approximately 
70%, although this is likely to be lower in soiled airways.8 Arguably, overall intubation success could 
also be an indication of intubation competence, but by not allowing multiple intubation attempts at 
each stage of the assessment, the participants are minimally inconvenienced in terms of time required 
to take part in the study, while still providing an objective measurements of the effect of the training 
intervention.
1.1
Assessment and management of risk
This overall risk of conducting this study is low. An airway training manikin will be utilised instead of 
patients to enable reliable repetition of intubation attempts. All equipment used in the study is standard 
equipment that paramedic participants will be familiar with, including personal protective equipment 
(eyewear and gloves) that is available for staff to wear during an intubation attempt.
The vomiting manikin is powered by a low voltage, direct current (DC) marine battery, which is not in 
direct contact with the manikin at any point. No mains voltage will be used at all. The motorised 
suction unit utilised will be the standard battery-powered model in use by the Service.
The ingredients for the artificial ‘vomit’ are water, food colouring, and xanthan gum: a gluten-free 
edible thickener. It is unlikely that ingestion of the simulated ‘vomit’ will occur, but topical exposure is 
possible and potential participants will be asked specifically about allergy to xanthan gum and food 
colouring ingredients, and excluded if this is the case. Eyewear and face masks (standard PPE) will be 
provided to protect against exposure to ‘vomit’. 
2
AIMS, OBJECTIVES AND OUTCOMES
2.1 Aim and research question
This study aims to determine whether a short teaching session of the SALAD technique to 
paramedics, improves their ability to intubate a contaminated airway. 
The research question is: Does paramedic first-pass intubation success of a simulated contaminated 
airway improve following training in Suction Assisted Laryngoscopy and Airway Decontamination 
(SALAD)?
The null hypothesis for this study is that there is no difference in paramedic first-pass intubation 
success rates of a simulated contaminated airway, between pre- and post-SALAD training intubation 
attempts.
2.2. Primary objective
To determine the difference between paramedic first-pass intubation success, before and after SALAD 
training, in a simulated soiled airway
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2.3
Secondary objective
To determine the difference in time taken to achieve first-pass intubation success, before and after 
SALAD training in a simulated soiled airway, and the effect of multiple intubation attempts on success 
rates following SALAD training.
2.4
Primary endpoint/outcome
The primary outcome is the difference in proportions of paramedic first-pass intubation success, 
before and after SALAD training
2.5
Secondary endpoints/outcomes
The secondary outcomes are:

Mean of the differences in intubation attempt times, between first and second intubation 
attempts, and between pre- and post-training attempts

Difference in success rates between participants who have two post-training intubation 
attempts versus participants who only have one post-training intubation attempt.
3
TRIAL DESIGN
The trial has been designed as a randomised controlled trial (RCT), with the primary objective of 
determining whether first-past intubation success rates are higher in the post-SALAD training group of 
participants. In order to adjust for changes in participant performance by making repeated attempts at 
intubation, paramedics will be randomised into either: making two pre-training intubation attempts and 
one post-training attempt (AAB); or making one pre-training intubation attempt and two post-training 
attempts (ABB).
4
TRIAL SETTING
This study will be conducted at a single site (YAS). All sessions will be conducted on Trust premises, 
typically ambulance stations or other training facilities around the Trust, which are geographically 
convenient for participants to attend. Participants will be NHS staff who are employed by YAS, and 
who are Health and Care Professions Council (HCPC) registered paramedics. 
5
PARTICIPANT ELIGIBILITY CRITERIA
5.1
Inclusion criteria
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●
Aged 18 and over
●
HCPC registered paramedic employed by Yorkshire Ambulance Service
●
Authorised to intubate within Yorkshire Ambulance Service
●
No SALAD training in the last 3 months
5.2
Exclusion criteria
●
Not an HCPC registered paramedic employed by Yorkshire Ambulance Service
●
Not authorised to intubate within Yorkshire Ambulance Service
●
Allergy to artificial ‘vomit’ ingredients
●
Unwilling to provide consent
●
SALAD training in the last 3 months
6
TRIAL PROCEDURES 
6.1
Recruitment
Potential participants will be invited indirectly to participate via Trust email and the weekly operational 
update that is widely distributed throughout the Trust. This will include simultaneous distribution of the 
PIS via the same route. 
Paramedics who are interested in the study will be asked to contact the CI to arrange attendance at a 
study training session. The CI will confirm that the potential participant is an operational paramedic 
working for the Trust, and is not allergic to the ‘vomit’ ingredients. This will be documented on a 
spreadsheet of potential participants.
All participants will have their travel mileage refunded at a rate of 45p/mile.
6.2 Consent 
All participants will have capacity as they are operational paramedics and employees of Yorkshire 
Ambulance Service NHS Trust. At the start of the study training session, informed consent will be 
obtained by the CI and verified by completion of a signed consent form.
6.3
Withdrawal criteria 
Participants can withdraw from the trial at any time and do not have to provide justification for doing 
so, by contacting the CI for the trial. Details of the withdrawal will be entered onto the CRF. 
Participants who withdraw, can request that any non-anonymised data is erased.
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Since the sample size is required to ensure the study is adequately powered, additional paramedic 
participants will be recruited, if necessary, to offset any withdrawals. For the same reason, this study 
will continue until the sample size has been reached.
7
INTERVENTION UNDER STUDY
7.1 SALAD manikin
The manikin to be used in the study is a modified TruCorp AirSim Advance, which has realistic airway 
anatomy and can be used for tracheal intubation training. The oesophagus of this manikin has been 
connected, via a hosepipe, to a bilge pump that is sited within a reservoir of simulated vomit. The 
vomit is water, coloured with food-grade colouring, and thickened with xanthan gum (a food additive). 
Once the bilge pump is switched on, it can generate a constant flow of liquid into the oropharynx, 
obscuring any view of the laryngeal inlet. The flow rate is controlled by a tap, which will be calibrated 
to provide 1 L/min of vomit to the oropharynx of the manikin during the intubation attempts. To keep 
vomit within the oropharynx, the left and right bronchi on the manikin have been occluded. 
An endoscope camera will be placed in the posterior oropharynx after each intubation attempt and 
connected to a laptop, to provide a view of the vocal cords for the researcher, but not the participant, 
allowing confirmation of correct tube placement, while not obstructing the view of the paramedic 
participant attempting direct laryngoscopy. 
Standard intubation equipment, including personal protective equipment (PPE) and motorised suction, 
that is routinely used within YAS will be provided for participants, and the study researcher will act as 
a competent assistant for the intubation attempts.
7.2 Procedure
Informed consent will be obtained from paramedic participants prior to commencing the study. They 
will then be randomised to determine the order in which they will attempt intubation, and whether they 
will make two pre-training and one post-training attempts (AAB group), or one pre-training and two 
post-training attempts (ABB group). All attempts will utilise direct laryngoscopy, which is the standard 
intubation technique within YAS. Prior to each intubation attempt, the manikin will be primed with 
vomit. Once the oropharynx is full, the participant will undertake their first intubation attempt. The 
manikin will deliver vomit to the oropharynx at a rate of 1L/min.
All intubation attempts will be video recorded to allow for accurate time-keeping, since the researcher 
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will be assisting the paramedic with their intubation attempt. However, the researcher will also time the 
intubation attempt using a stopwatch to record the time, in the event that a video recording fails. 
Participants will be deemed to have begun their intubation attempt once pump which makes the 
manikin vomit, is turned on. The attempt will be considered over when:

The paramedic who has intubated the manikin verbally confirms with the researcher that the 
attempt has been completed or;

90 seconds has elapsed or;

The tracheal tube is placed into the oesophagus and the cuff is inflated while the pump is still 
running.
If the tracheal tube is not in the trachea, with the cuff inflated and connected to a bag-valve device 
within 90 seconds, the attempt will be considered a failure.
Participants randomised to the two pre-training attempts (AAB) will make a second intubation attempt 
prior to the group training session. Once all participants have completed their pre-training intubation 
attempt, the training session will be delivered, and will take around 45 minutes to complete, including 
time for participant practice. The training intervention will adopt the Advanced Life Support 
Group/Resuscitation Council 4-stage approach of skills teaching, and is comprised of:9
1.
A real-time demonstration of the SALAD technique by the researcher
2.
A repeated demonstration with an explanation of the rationale of the steps taken when 
performing SALAD (not real-time)
3.
Another demonstration of the SALAD technique conducted by the researcher, but guided by 
one of the participants
4.
An attempt by the same participant who guided the researcher in the previous step, followed by 
a practice attempt by the other participants.
Following the training session, participants will make their post-training intubation attempt(s). This will 
be conducted using the same method as for the pre-training intubation attempt(s). Participants 
randomised into the two post-training attempts (ABB), will make their second attempt immediately 
following the first post-training attempt.
8
STATISTICS AND DATA ANALYSIS
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8.1
Sample size calculation
The null hypothesis (H0) for this study is that the training intervention will have no effect on participant 
intubation success. The alternative hypothesis (H1) is that intubation success will change following the 
training intervention.
A sample size of 154 participants is required to determine a change in the proportion of intubation 
success, from 0.25 in the pre-training group, to 0.50 in post-training group, with a power (1-β) of 90% 
and a significance level (α) of 5%. Given that there is no literature to guide expected performance, a 
conservative estimate has been made in consultation with an internationally recognised SALAD 
expert, Dr. James DuCanto (J.DuCanto, personal communication, April 26, 2018).
The sample size calculation was determined by using the application G*Power, version 3.1, using the 
parameters and test shown in Figure 1. No subgroup analyses or adjustment of the analysis to 
account for the demographic data obtained from participants will be undertaken.
Figure 1: G*Power parameters for study sample size calculation
8.2
Planned recruitment rate
Recruitment is planned to occur between July and December, 2018 with 6–8 sessions per month 
comprised of 3–6 participants per session.
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8.3
Statistical analysis plan
8.3.1
Summary of baseline data and flow of patients
Descriptive statistics will be used to summarise the demographic data provided by participants. The 
order pathway that participants make their intubation attempts (AAB or ABB) will be 1:1 randomised, 
using a block randomisation sequence provided by RANDOM.ORG. In addition, block randomisation 
will be utilised to allocate participants into either the AAB or ABB group. To distinguish between the 
training pathways and number of the assessed attempts, we will use A01A02B01 and A11B11B12 to 
differentiate between groups and attempts.
8.3.2
Primary outcome analysis
To determine if the training has an effect and increases the success rate of intubation, we will 
compare the proportions of success in the groups who receive no training before their 2nd intubation 
attempt (A02), with those who do receive training before their 2nd intubation attempt (B11). Comparing 
the rates at these time points, controls for any learning effect due to participants making more than 
one attempt at intubation. The difference in the two proportions will be analysed using a two 
independent samples proportion z-test. We will assume a two-sided type 1 error rate of 5%, and report 
the proportions and the difference in the proportions along with 95% confidence intervals.
8.3.3
Secondary outcome analysis
Intubation times will be truncated at 90 seconds. We will compare the mean of the differences (A01 – 
A02) with the mean of differences (A11 – B11). We will also compare the mean of the differences seen at 
the final measurements, (A01 – B01) and (A11 – B12), to see if there are differences between the two 
pathways, which might suggest that practice following the training, further improves the time to 
successful intubation. In addition, we will also compare the success rates between B01 and B02 to see 
whether practice following training improves intubation success rate. A Student’s t-test will be utilised 
to test for the differences between mean pre- and post-training intubation attempt times. The 
difference in success rates, will be analysed using a two independent samples proportion z-test. We 
will assume a two-sided type 1 error rate of 5%, and report the proportions and the difference in the 
proportions along with 95% confidence intervals.
8.4
Procedure(s) to account for missing or spurious data 
In the event that the video recording cannot be used to determine intubation success and time to 
success, the researcher recorded outcomes will be utilised instead. Should a participant not complete 
all three attempts, then their data will not be included in the final analysis and a replacement 
participant sought to ensure that the target sample size is achieved.
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9
DATA MANAGEMENT 
9.1
Data collection tools and source document identification
The source data for the study will consist of a custom case report form and video recordings. 
9.2
Data handling and record keeping 
The CRF will be completed by the CI during the participant attempts. This will include the basic 
demographic data, whether the first-pass intubation is successful, if the tube was suctioned prior to an 
attempt at ventilation, and the time taken to intubate. 
To minimise the chance of missing data, participants will be advised that the will not be able to 
participate in the study if they do not know how many intubations they have performed in the 
preceding 12 months, or if they have received training in SALAD in the past 3 months. In addition, 
although the most accurate time to intubate will be available from the video, the CI will also have a 
stopwatch to record the time in case of video failure.
To maintain participant confidentiality, the CRF will not contain any personal-identifiable data. Instead, 
the participant will be identified by a unique study ID.
Video recordings of the training sessions will be held securely on a Trust computer which only the 
researcher can access. Once timings and confirmation of intubation success have been determined 
following review of the video, the recording will be erased (within one week, typically). Participants will 
not be identifiable from the data produced by the trial.
All CRFs will be securely stored on Trust premises in a locked cabinet, within a secure room.
9.3
Access to Data
Direct access will be granted to authorised representatives from the Sponsor, host institution and the 
regulatory authorities to permit trial-related monitoring, audits and inspections in line with participant 
consent.
9.4
Archiving
Archiving will be authorised by the Sponsor following submission of the end of trial report. All source 
documentation will be archived on Trust premises in a locked cabinet in a secure location. Video 
recordings will not be archived as they will be securely erased during the study.
Data will be available for future analysis for a period of 2 years prior to being archived. All essential 
documents will be archived for a minimum of 5 years after completion of trial. Destruction of essential 
documents will require authorisation from the Sponsor.
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10
MONITORING, AUDIT & INSPECTION
The study may be audited as part of the routine audit process as laid out in the Sponsors Research 
Governance Policy. All source documents and essential documents will be available to the sponsor for 
audit for at least five years. 
11 
ETHICAL AND REGULATORY CONSIDERATIONS
11.1 Research Ethics Committee (REC) review and reports
Prior to the start of the trial, approval will be sought from a REC for the trial protocol, informed consent 
forms and other relevant documents. Substantial amendments that require review by REC will not be 
implemented until the REC grants a favourable opinion for the trial, and all correspondence with the 
REC will be retained in the Trial Master File. If the trial is ended prematurely, the Chief Investigator will 
notify the REC, including the reasons for the premature termination.
11.2 Peer review
Peer review has been provided as part of the funding application process and was proportionate, 
independent and expert.
11.3 Public and Patient Involvement
YAS is fortunate to have a Patient Research Ambassador (PRA) who has been involved in the 
production of lay summaries and sense-checking of documents, in addition to advising on the 
proposed dissemination plan.
11.3 Protocol compliance 
Any breach of protocol will be reported via the YAS Datix system to notify the Research and 
Development department at YAS. Duty of Candour will be considered in consultation with the YAS 
Duty of Candour specialist.
11.4 Data protection and participant confidentiality 
All investigators and trial site staff will comply with the requirements of the Data Protection Act 
1998/General Data Protection Regulations 2018 (whichever is in force at the time of the study being 
undertaken) with regards to the collection, storage, processing and disclosure of personal information.. 
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Each participant will be allocated a participant ID once informed consent has been obtained. This will 
be used on all study source documents. Access to the source documents will be restricted to YAS 
research and development (R&D) personnel only. Video recordings will only be accessible by the CI, 
the data custodian.
Video recordings of the training sessions will be held securely on a Trust computer which only the CI 
can access. Once timings and confirmation of intubation success have been determined following 
review of the video, the recording will be securely erased. Participants will not be identifiable from the 
data produced by the trial. All CRFs will be securely stored on Trust premises in a locked cabinet, 
within a secure room.
An anonymised version of the dataset will be made available for other researchers.
11.5 Financial and other competing interests for the chief investigator, PIs at each site and 
committee members for the overall trial management 
The chief investigator has no financial or other competing interests that might influence the trial 
design, conduct or reporting. The technique that is the focus of this trial is not ‘owned’ and the 
equipment used is standard issue to Trust paramedics.
11.6 Indemnity
The study sponsor will assume all liability for the study activities.
11.7 Amendments 
Any amendments to the protocol will be submitted to the HRA for categorisation and consideration as 
appropriate.
11.8 Access to the final trial dataset
The chief investigator and the statistician will be the only personnel to have access to the full dataset 
for the purposes of this study analysis.
12 
DISSEMINATION POLICY
12.1 Dissemination policy 
The results of the study will be published in a peer-reviewed journal such as the British Paramedic 
Journal and presented at relevant conferences such as the College of Paramedics national 
conference, 999 EMS Research forum and EMS2019. In addition, plain English summaries will be 
published in the College of Paramedics newsletter and free ambulance magazines, which are routinely 
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posted to all ambulance stations in the UK. A summary report will be presented to the participants and 
YAS, and will be available on the study website (https://satiated.ambulanceresearch.co.uk). Finally, 
the ubiquity of social-media will be utilised to highlight the publication of the study on Twitter, 
Facebook and other social media outlets.
12.2 Authorship eligibility guidelines and any intended use of professional writers
Since part of the dissemination strategy involves publishing in peer-reviewed journals, author eligibility 
will be determined in according with The International Committee of Medical Journal Editors (ICMJE) 
authorship criteria. Professional writers will not be used.
13
REFERENCES
 
 
1. Voss S, Rhys M, Coates D, Greenwood R, Nolan JP, Thomas M, et al. How do paramedics manage 
the airway during out of hospital cardiac arrest? Resuscitation. 2014 Dec;85(12):1662–6.
2. Simons RW, Rea TD, Becker LJ, Eisenberg MS. The incidence and significance of emesis 
associated with out-of-hospital cardiac arrest. Resuscitation. 2007 Sep;74(3):427–31.
3. Sakles JC, Corn GJ, Hollinger P, Arcaris B, Patanwala AE, Mosier JM. The Impact of a Soiled 
Airway on Intubation Success in the Emergency Department When Using the GlideScope or the Direct 
Laryngoscope. Reardon R, editor. Acad Emerg Med. 2017 May;24(5):628–36.
4. Christ M, von Auenmueller KI, Amirie S, Sasko BM, Brand M, Trappe H-J. Early-Onset Pneumonia 
in Non-Traumatic Out-of-Hospital Cardiac Arrest Patients with Special Focus on Prehospital Airway 
Management. Med Sci Monit Int Med J Exp Clin Res. 2016 Jun 13;22:2013–20.
5. DuCanto J, Serrano KD, Thompson RJ. Novel Airway Training Tool that Simulates Vomiting: 
Suction-Assisted Laryngoscopy Assisted Decontamination (SALAD) System. West J Emerg Med. 
2017 Jan;18(1):117–20.
6. Kei J, Mebust DP. Comparing the Effectiveness of a Novel Suction Set-up Using an Adult 
Endotracheal Tube Connected to a Meconium Aspirator vs. a Traditional Yankauer Suction 
Instrument. J Emerg Med. 2017 Apr 1;52(4):433–7.
7. Kornhall DK, Almqvist S, Dolven T, Ytrebø LM. Intentional oesophageal intubation for managing 
regurgitation during endotracheal intubation. Anaesth Intensive Care. 2015 May;43(3):412–4.
8. Crewdson K, Lockey DJ, Røislien J, Lossius HM, Rehn M. The success of pre-hospital tracheal 
intubation by different pre-hospital providers: a systematic literature review and meta-analysis. Crit 
Care. 2017 Feb 14;21:31.
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9. Bullock I, Davis M, Lockey A, Mackway-Jones K. Pocket guide to teaching for medical instructors. 
2nd ed. Malden: BMJ Books; 2008.
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14. APPENDICES
14.1
Appendix 1 – Amendment History
Amendment 
No.
Protocol 
version no.
Date issued
Author(s) of 
changes
Details of changes made
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