search
Back to results

Cricothyroidotomy Training for Physicians Outcomes Study

Primary Purpose

Airway Obstruction

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Porcine model
Synthetic model
Sponsored by
The Royal Wolverhampton Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Airway Obstruction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Royal Wolverhampton NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Porcine Group

Synthetic

Arm Description

Training conducted on Porcine model

Training conducted on synthetic model

Outcomes

Primary Outcome Measures

Time to successfully complete surgical cricothyroidotomy on a prepared porcine specimen.
time

Secondary Outcome Measures

Success rate for cricothyroidotomy
subjective reporting of confidence through questionnaire
Complication rate for cricothyroidotomy
subjective reporting of confidence through questionnaire

Full Information

First Posted
July 25, 2017
Last Updated
August 13, 2019
Sponsor
The Royal Wolverhampton Hospitals NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT03238950
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
This study has never actually started as waiting on funding
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Wolverhampton Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Assessment of ability to complete a surgical cricothyroidotomy 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Porcine Group
Arm Type
Other
Arm Description
Training conducted on Porcine model
Arm Title
Synthetic
Arm Type
Other
Arm Description
Training conducted on synthetic model
Intervention Type
Other
Intervention Name(s)
Porcine model
Intervention Description
participants to conduct training on porcine model
Intervention Type
Other
Intervention Name(s)
Synthetic model
Intervention Description
participants to conduct training on synthetic model
Primary Outcome Measure Information:
Title
Time to successfully complete surgical cricothyroidotomy on a prepared porcine specimen.
Description
time
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Success rate for cricothyroidotomy
Description
subjective reporting of confidence through questionnaire
Time Frame
1 day
Title
Complication rate for cricothyroidotomy
Description
subjective reporting of confidence through questionnaire
Time Frame
1 day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Helme
Organizational Affiliation
The Royal Wolverhampton NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Wolverhampton NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan

Learn more about this trial

Cricothyroidotomy Training for Physicians Outcomes Study

We'll reach out to this number within 24 hrs