Cricothyroidotomy Training for Physicians Outcomes Study

NCT ID: NCT03238950

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Airway Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Porcine Group

Training conducted on Porcine model

Group Type OTHER

Porcine model

Intervention Type OTHER

participants to conduct training on porcine model

Synthetic

Training conducted on synthetic model

Group Type OTHER

Synthetic model

Intervention Type OTHER

participants to conduct training on synthetic model

Interventions

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Porcine model

participants to conduct training on porcine model

Intervention Type OTHER

Synthetic model

participants to conduct training on synthetic model

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Royal Wolverhampton Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Helme

Role: PRINCIPAL_INVESTIGATOR

The Royal Wolverhampton NHS Trust

Locations

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The Royal Wolverhampton NHS Trust

Wolverhampton, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2017SUR96

Identifier Type: -

Identifier Source: org_study_id

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