Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics (SATIATED)

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

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.

Study Overview

• Status: Completed
• Conditions: Vomiting; Airway Management; Laryngoscopy; Intubation, Intratracheal
• Intervention / Treatment: Other: Training in SALAD technique

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Wakefield, West Yorkshire, United Kingdom, WF2 0XQ
      • Yorkshire Ambulance Service NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time 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 Attempt	pre- and post-training as part of 2 hour study session

Collaborators and Investigators

• Sponsor: Yorkshire Ambulance Service NHS Trust
• Collaborators: College of Paramedics
• Investigators: Principal Investigator: Richard Pilbery, Yorkshire Ambulance Service NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): December 3, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: YASRD100; 245954 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No