Cricothyroidotomy Training for Physicians Outcomes Study

In Cricothyroidotomy Training for Physicians Does Simulated Practice With Tissue Specimens Produce Better Outcomes Than Using Synthetics Manikins?

This study will assess whether the type of simulation model used in cricothyroidotomy training has an effect on the subsequent confidence and competence in the procedure.

Study Overview

• Status: Withdrawn
• Conditions: Airway Obstruction
• Intervention / Treatment: Other: Porcine model; Other: Synthetic model

Detailed Description

This is a Pilot study - prospective randomised controlled trial involving:

1. Assessment of ability to complete a surgical cricothyroidotomy
2. Completion of questionnaire prior to training and prior to assessment

Prior to beginning training, questionnaires will be completed by all participants asking their level of previous training. Current confidence level for completion of cricothyroidotomy will be marked on a visual analogue scale (VAS).

Training will then be completed with each group using the appropriate manikin type - porcine or synthetic. This will consist of didactic information on the procedure delivered via recorded information to standardise this initial training, and then proceeding to supervised practice of the procedure for two occasions. This will be completed by the same trainer, with the same information given to both groups. Questions to clarify how to perform the procedure will be permitted.

The second questionnaire will be given to the trainees on completion of training to mark on a visual analogue scale their confidence level at this point.

Assessment will then be completed later the day comprising of assessment of completion of surgical cricothyroidotomy using a porcine manikin with skin overlying. This will be different to the porcine manikin used for training. The assessment will time the trainees from start to completion of airway insertion, as well as a checklist of activities to be achieved. The porcine manikins will then be dissected to identify if correct location for insertion was achieved and complications. The same amount of time will be given between groups training and assessment.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Wolverhampton, United Kingdom, WV10 0QP
    • The Royal Wolverhampton NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medically trained healthcare professionals working in Anaesthetics, Emergency Medicine or General Surgery as these doctors may be expected to complete a surgical cricothyroidotomy despite infrequently performing the procedure.
• The healthcare professionals can be from Foundation Year 1 to before Certificates of Completion of Training (CCT). Those who are out of training and are not yet at consultant level are also eligible.
• Able to provide informed consent.

Exclusion Criteria:

• Healthcare professionals who already complete surgical airways on a regular basis (e.g. Ear Nose Throat or Maxillofacial trainees) as these doctors may already be competent prior to training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Porcine Group; Training conducted on Porcine model	Other: Porcine model; participants to conduct training on porcine model
Other: Synthetic; Training conducted on synthetic model	Other: Synthetic model; participants to conduct training on synthetic model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to successfully complete surgical cricothyroidotomy on a prepared porcine specimen.	time	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate for cricothyroidotomy	subjective reporting of confidence through questionnaire	1 day
Complication rate for cricothyroidotomy	subjective reporting of confidence through questionnaire	1 day

Collaborators and Investigators

• Sponsor: The Royal Wolverhampton Hospitals NHS Trust
• Investigators: Principal Investigator: Michael Helme, The Royal Wolverhampton NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: 2017SUR96

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no plan

Drug and device information, study documents

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