Condition category
Respiratory
Date applied
03/06/2019
Date assigned
06/06/2019
Last edited
06/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
In more than one-in-five cases of out-of-hospital cardiac arrest, airways are blocked by vomit and blood. Sometimes, paramedics cannot clear the airway using methods they have been taught. If the airway cannot be cleared, the patient will die. Usually, these patients will have a breathing tube placed into their windpipe (intubation), as this provides protection from vomit and blood. To do this, the paramedic needs to be able to see the entrance to the windpipe. A new method of clearing the airway called SALAD has been used in patients to help insert a breathing tube, but it is not known whether the method can help paramedics. This study will use a manikin to see if paramedics can insert a breathing tube more often on their first attempt, using SALAD.

Who can participate?
Paramedics employed by North East Ambulance Service NHS Trust

What does the study involve?
The study involves paramedics being tested on their ability to secure the airway of a simulated patient (manikin) when the airway is full of fluid. The paramedics are then trained on a technique (SALAD) to deal with this type of situation and then tested again to see if their abilities improve. Participants are randomly allocated to make either one or two attempts before the training session on the SALAD technique, or one or two attempts after. All attempts are filmed to ensure accurate time-keeping. Participants have additional practice attempts at intubation during the training session.

What are the possible benefits and risks of participating?
The paramedics will learn and practice a technique that will hopefully allow them to better deal with a patient who has an airway that is full of fluid which would be beneficial if that situation arose. There are no risks to participating.

Where is the study run from?
North East Ambulance Service NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
April 2019 to November 2019

Who is funding the study?
SSCOR, Inc.

Who is the main contact?
Dr Graham McClelland
graham.mcclelland@neas.nhs.uk

Trial website

https://satiated2.netlify.com/

Contact information

Type

Scientific

Primary contact

Dr Graham McClelland

ORCID ID

http://orcid.org/0000-0002-4502-5821

Contact details

North East Ambulance Service NHS Foundation Trust
Work Address Bernicia House
Goldcrest Way
Newburn Riverside
Newcastle Upon Tyne
NE15 8NY
United Kingdom
+44 (0)1914302244
graham.mcclelland@neas.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

42102

Study information

Scientific title

Soiled airway tracheal intubation and the effectiveness of decontamination by North East paramedics: a randomised controlled manikin study

Acronym

SATIATED2

Study hypothesis

Does training in the Suction Assisted Laryngoscopy and Airway Decontamination (SALAD) technique improve the
ability of paramedics to successfully insert a breathing tube (intubation) into the windpipe of a manikin which is
vomiting?

Ethics approval

Ethics approval is not necessary for this study as it is staff based

Study design

Randomised; Interventional; Design type: Process of Care, Education or Self-Management

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Soiled airway tracheal intubation

Intervention

Paramedics who wish to take part in the trial will contact the researcher to arrange attendance at a study training session. When a paramedic participant attends, they will be asked to give informed consent by completing the study consent form. In addition, to take account of learning that might occur by making multiple intubation attempts, participants will be randomised into one of two groups: AAB, where they will have two pre-training intubation attempts, and one post-training attempts; or ABB, where they will have one pre-training intubation attempt, and two post-training attempts.

Prior to each intubation attempt, the manikin will be primed with vomit. Once the mouth is full of vomit, the participant will undertake their first intubation attempt. The manikin will then deliver vomit to the mouth at a rate of one litre per minute. All intubation attempts will be video recorded to allow for accurate time-keeping, since the researcher will be assisting the paramedic with their intubation attempt. An intubation attempt will start when the researcher turns on the pump to make the manikin vomit. The attempt will be considered over when any of the following occur: the paramedic who has intubated the manikin tells the researcher that the attempt has been completed; 90 seconds has passed; the breathing tube is placed into the gullet and the balloon at the end of the breathing tube is inflated while the pump is still running. If the breathing tube is not in the windpipe, with the breathing tube cuff inflated and connected to a bagvalve device within 90 seconds, the attempt will be considered a failure.
Once all participants have completed their pre-training intubation attempt(s), 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:
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 realtime)
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).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Difference in proportions of paramedic intubation success before and after training

Secondary outcome measures

1. Mean of the differences in intubation attempt times (measured in seconds) between first and second intubation attempts and between pre- and post-training attempts
2. Difference in success rates between participants who have two post-training intubation attempts versus participants who only have one post-training intubation attempt
3. Comparison of SATIATED2 and SATIATED outcomes

Overall trial start date

01/04/2019

Overall trial end date

01/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 and over
2. HCPC registered paramedic employed by NEAS
3. Authorised to intubate within NEAS
4. No SALAD training in the last 3 months

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Not an HCPC registered paramedic employed by NEAS
2. Not authorised to intubate within NEAS
3. Allergy to artificial ‘vomit’ ingredients
4. Unwilling to provide consent
5. SALAD training in the last 3 months

Recruitment start date

01/07/2019

Recruitment end date

30/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North East Ambulance Service NHS Foundation Trust
Benicia House Goldcrest Way Newburn Riverside
Newcastle Upon Tyne
NE15 8NY
United Kingdom

Sponsor information

Organisation

North East Ambulance Service NHS Foundation Trust

Sponsor details

Benicia House
Goldcrest Way
Newburn Riverside
Newcastle Upon Tyne
NE15 8NY
United Kingdom
+44 (0)1914302294
michelle.jackson@neas.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

SSCOR, Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Peer reviewed scientific journals
2. Internal report
3. Conference presentation

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/11/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/06/2019: Trial's existence confirmed by the NIHR.