NCT05396768

Brief Summary

The aim of this study is to collect validity evidence for the ACTION-tool on two different simulators: a porcine rib model, and Thiel embalmed human cadavers. Validity evidence will be collected following Messick's framework.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

May 16, 2022

Last Update Submit

April 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Score on on the ACTION-tool

    The main goal is the collection of validity evidence for the ACTION-tool following Messick's framework. This is done by recording the score each participant receives while being assessed using the ACTION-tool. The minimum score on the rating scale is 17, the maximum 85 (a higher score indicates a better performance). On the error checklist the minimum score is 0, maximum score is 16 (where a lower score is less observed errors).

    Immediately after performing a CTI on the simulator.

Study Arms (2)

Novices

Junior residents from the departments of surgery, pneumology or emergency medicine. These participants are in their first or second year of residency, and have observed or placed less than 5 CTIs in their career.

Other: Assessment using the ACTION-tool.

Experienced

Faculty members from Ghent University Hospital from the departments of surgery, pneumology or emergency medicine. These participants must have finished their residency training, and must be involved in resident education.

Other: Assessment using the ACTION-tool.

Interventions

Participants will be assessed using the ACTION-tool while they are performing a CTI on a porcine rib model and Thiel embalmed human cadavers.

ExperiencedNovices

Eligibility Criteria

Age24 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All participants will be recruited from Ghent University Hospital. Experienced participants are faculty members, and the novice group is recruited from the resident population.

You may qualify if:

  • Experienced participants must hold a degree of Master in Medicine, and must have finished the residency training specific to their field (attending physician).
  • Novice participants are defined as junior residents who are graduated as Master in Medicine and must be in their first two years of residency training, or be at least in their 3rd Master year of Medicine and be accepted as starting resident.

You may not qualify if:

  • Experienced participants who lack experience or the appropriate diplomas will be excluded.
  • Novices who have performed more than five CTI or assisted in the placement of more than five procedures will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Study Officials

  • Wouter Willaert, Prof. Dr.

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 31, 2022

Study Start

November 18, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations