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Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics

Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics (SATIATED): A Randomised Controlled Manikin Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03599687
Acronym
SATIATED
Enrollment
164
Registered
2018-07-26
Start date
2018-07-16
Completion date
2019-02-28
Last updated
2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management, Intubation, Intratracheal, Laryngoscopy, Vomiting

Brief 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.

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.

Sponsors

College of Paramedics
CollaboratorUNKNOWN
Yorkshire Ambulance Service NHS Trust
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Difference in First-pass Intubation Success Rates Before and After SALAD Trainingpre- and post-training as part of 2 hour study sessionThis 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.

Secondary

MeasureTime frame
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.seconds
Difference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attemptpre- and post-training as part of 2 hour study session

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Group AAB
In order to adjust for improvements in participant performance that might arise from repeated attempts at intubation, beyond that of the SALAD training itself, paramedics were randomised into one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts.
82
Group ABB
Participants randomised into making one pre-training and two post-training intubation attempts.
82
Total164

Baseline characteristics

CharacteristicGroup AABGroup ABBTotal
Age, Customized
Adults > 18 years
82 Participants82 Participants164 Participants
Awareness of SALAD technique15 Participants21 Participants36 Participants
Intubation attempts in past 12 months2.5 attempts3.0 attempts3.0 attempts
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United Kingdom
82 participants82 participants164 participants
Sex/Gender, Customized
Gender Unknown
82 Participants82 Participants164 Participants
Successful intubation attempts in past 12 months2 attempts2 attempts2 attempts
Years as a paramedic5 years3.5 years4 years

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 820 / 82
other
Total, other adverse events
0 / 820 / 82
serious
Total, serious adverse events
0 / 820 / 82

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group AABDifference in First-pass Intubation Success Rates Before and After SALAD Training44 Participants
Group ABBDifference in First-pass Intubation Success Rates Before and After SALAD Training74 Participants
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group AABDifference 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 secondsStandard Error 3.5
Group ABBDifference Between Mean Time Taken (in Seconds) to Perform a Successful Intubation on the First- Attempt, Before and After SALAD Training Approximately 30 Minutes Apart.3.7 secondsStandard Error 3.4
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group AABDifference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt71 Participants
Group ABBDifference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt73 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026