NCT03599687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 13, 2020

Completed
Last Updated

August 13, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 12, 2018

Results QC Date

July 16, 2019

Last Update Submit

July 29, 2020

Conditions

Outcome Measures

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.

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

Secondary Outcomes (2)

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yorkshire Ambulance Service NHS Trust

Wakefield, West Yorkshire, WF2 0XQ, United Kingdom

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Manikin study Vomit did not contain solid material and was not odorous Participants not blinded from allocation

Results Point of Contact

Title
Richard Pilbery
Organization
Yorkshire Ambulance Service NHS Trust

Study Officials

  • Richard Pilbery

    Yorkshire Ambulance Service NHS Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2018

First Posted

July 26, 2018

Study Start

July 16, 2018

Primary Completion

December 3, 2018

Study Completion

February 28, 2019

Last Updated

August 13, 2020

Results First Posted

August 13, 2020

Record last verified: 2020-07

Locations