Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics

Vomiting Clinical Trial

— SATIATED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599687
• Other study ID #: YASRD100
• Secondary ID: 245954
• Status: Completed
• Start date: July 16, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: July 2020
• Source: Yorkshire Ambulance Service NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: February 28, 2019
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Management
• Intubation, Intratracheal
• Laryngoscopy
• Vomiting

Intervention

Other:
• Training 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.

Locations

Country	Name	City	State
United Kingdom	Yorkshire Ambulance Service NHS Trust	Wakefield	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Yorkshire Ambulance Service NHS Trust	College of Paramedics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	pre- and post-training as part of 2 hour study session
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.		seconds
Secondary	Difference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt		pre- and post-training as part of 2 hour study session