CClinicalTrials.gg
CompletedNCT03599687SATIATEDUpdated Aug 13, 2020Results posted

Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics

An observational study in Airway Management, Intubation, Intratracheal and Laryngoscopy, sponsored by Yorkshire Ambulance Service NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-08-13.

Sponsored by Yorkshire Ambulance Service NHS Trust · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
164
Ages
18 Years to 65 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Airway Management
  • Intubation, Intratracheal
  • Laryngoscopy
  • Vomiting

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03

In context

Vomiting

1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.

This study's enrollment of 164 is close to the median of 160 across 124 observational studies indexed under Vomiting.

Browse Vomiting studies →

Lead sponsor

Yorkshire Ambulance Service NHS Trust is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will be NHS staff who are employed by Yorkshire Ambulance Service NHS Trust, and who are Health and Care Professions Council (HCPC) registered paramedics.

Inclusion criteria

  • 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

Exclusion criteria

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
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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
164 participants (actual)
Patient registry
No

Interventions

  • OtherTraining in SALAD technique

    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: A real-time demonstration of the SALAD technique by the researcher; A repeated demonstration with an explanation of the rationale of the steps taken when performing SALAD (not real-time); Another demonstration of the SALAD technique conducted by the researcher, but guided by one of the participants; An attempt by the same participant who guided the researcher in the previous step, followed by a practice attempt by the other participants.

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What researchers measure

Primary outcomes

  1. Difference in First-pass Intubation Success Rates Before and After SALAD Training

    This measure is a comparison of Group AAB's first-pass intubation success rate, using an attempt which occurred before SALAD training, and Group ABB's intubation success rate, using an intubation attempt that occurred after SALAD training.

    Time frame: pre- and post-training as part of 2 hour study session

Secondary outcomes

  1. Difference Between Mean Time Taken (in Seconds) to Perform a Successful Intubation on the First- Attempt, Before and After SALAD Training Approximately 30 Minutes Apart.

    Time frame: seconds

  2. Difference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt

    Time frame: pre- and post-training as part of 2 hour study session

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Results

Posted Aug 13, 2020
Limitations and caveats
Manikin study Vomit did not contain solid material and was not odorous Participants not blinded from allocation

Participant flow

Participant flow — Overall Study
MilestoneGroup AABGroup ABB
Started8282
Completed8282
Not completed00

Outcome measures

PrimaryDifference in First-pass Intubation Success Rates Before and After SALAD Training

This measure is a comparison of Group AAB's first-pass intubation success rate, using an attempt which occurred before SALAD training, and Group ABB's intubation success rate, using an intubation attempt that occurred after SALAD training.

Time frame:
pre- and post-training as part of 2 hour study session
Reported as:
Count of participants · Participants
Difference in First-pass Intubation Success Rates Before and After SALAD Training
ParticipantsGroup AABGroup ABB
Difference in First-pass Intubation Success Rates Before and After SALAD Training4474
SecondaryDifference Between Mean Time Taken (in Seconds) to Perform a Successful Intubation on the First- Attempt, Before and After SALAD Training Approximately 30 Minutes Apart.
Time frame:
seconds
Reported as:
Mean · seconds
Difference Between Mean Time Taken (in Seconds) to Perform a Successful Intubation on the First- Attempt, Before and After SALAD Training Approximately 30 Minutes Apart.
secondsGroup AABGroup ABB
Difference Between Mean Time Taken (in Seconds) to Perform a Successful Intubation on the First- Attempt, Before and After SALAD Training Approximately 30 Minutes Apart.15.4 ± 3.53.7 ± 3.4
SecondaryDifference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt
Time frame:
pre- and post-training as part of 2 hour study session
Reported as:
Count of participants · Participants
Difference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt
ParticipantsGroup AABGroup ABB
Difference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt7173

Adverse events

Collected over Adverse events were monitored over the course of each study session, which lasted approximately 2 hours.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group AAB0/82 (0%)0/82 (0%)0/82 (0%)
Group ABB0/82 (0%)0/82 (0%)0/82 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)Group AABGroup ABBTotal
Adults > 18 years8282164
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Group AABGroup ABBTotal
Gender Unknown8282164
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Group AABGroup ABBTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Group AABGroup ABBTotal
United Kingdom8282164
Intubation attempts in past 12 months
Intubation attempts in past 12 months(attempts)Group AABGroup ABBTotal
Median2.5 (0 to 6)3.0 (1 to 7)3.0 (1 to 6.5)
Successful intubation attempts in past 12 months
Successful intubation attempts in past 12 months(attempts)Group AABGroup ABBTotal
Median2 (0 to 5)2 (0 to 6)2 (0 to 6)
Years as a paramedic
Years as a paramedic(years)Group AABGroup ABBTotal
Median5 (1 to 10)3.5 (0 to 10)4 (1 to 10)
Awareness of SALAD technique
Awareness of SALAD technique(Participants)Group AABGroup ABBTotal
Count of participants152136
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Study locations

1 site
  • Yorkshire Ambulance Service NHS Trust
    Wakefield, West Yorkshire WF2 0XQ, United Kingdom
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References and documents

Study documents

  • Protocol and statistical analysis plan · May 25, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03599687
Lead sponsor
Yorkshire Ambulance Service NHS Trust
Collaborators
College of Paramedics
Responsible party
Sponsor
First posted
Jul 26, 2018
Start date
Jul 16, 2018
Primary completion
Dec 3, 2018
Completion
Feb 28, 2019
Results posted
Aug 13, 2020
Last update
Aug 13, 2020

Study contacts

Richard Pilbery
principal investigator · Yorkshire Ambulance Service NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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