Clinical trial NCT03238950: Cricothyroidotomy Training for Physicians Outcomes Study
Official title: In Cricothyroidotomy Training for Physicians Does Simulated Practice With Tissue Specimens Produce Better Outcomes Than Using Synthetics Manikins?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Airway Obstruction
Lead sponsor: The Royal Wolverhampton Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2017-08-03
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to successfully complete surgical cricothyroidotomy on a prepared porcine specimen.
timeFrame: 1 day
Secondary outcomes:
measure: Success rate for cricothyroidotomy
timeFrame: 1 day
measure: Complication rate for cricothyroidotomy
timeFrame: 1 day
Other outcomes:
Locations:
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
Study officials:
affiliation: The Royal Wolverhampton NHS Trust
name: Michael Helme
role: PRINCIPAL_INVESTIGATOR
References: