NCT03238950

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
1.9 years until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

July 25, 2017

Last Update Submit

August 13, 2019

Conditions

Airway Obstruction

Outcome Measures

Primary Outcomes (1)

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

    time

    1 day

Secondary Outcomes (2)

  • Success rate for cricothyroidotomy

    1 day

  • Complication rate for cricothyroidotomy

    1 day

Study Arms (2)

Porcine Group

OTHER

Training conducted on Porcine model

Other: Porcine model

Synthetic

OTHER

Training conducted on synthetic model

Other: Synthetic model

Interventions

Porcine modelOTHER

participants to conduct training on porcine model

Porcine Group
Synthetic modelOTHER

participants to conduct training on synthetic model

Synthetic

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Michael Helme

    The Royal Wolverhampton NHS Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 3, 2017

Study Start

July 1, 2019

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

no plan

Locations

GB(1)