NCT05134818

Brief Summary

Learning to insert a central venous catheter (CVC) is essential in anesthesiology and the use of simulation is recommended. Since 2017, this training has been integrated into the curriculum for incoming first year anesthesia residents in Île de France and combines a theoretical part (flipped classroom) and a practical part on a simulator. Given the large number of residents, the time to teach the procedure during the simulation session is limited. To increase the positive effects of the simulation when the learner is in the role of observer, some authors have proposed to strengthen the educational effect through the use of an observer tool that observers must complete by analyzing the progress of the task performed by their colleagues. This is a list describing the set of key points to be achieved. However, data concerning the educational value of these observer tools are limited. Studies on the use of these tools during crisis management training in the operating room assessed by high-fidelity simulation has been already conducted but not on their use during procedural simulation. The objective of this study will be to assess the value of using an observer tool (OT) (including the key points during the insertion of an internal jugular CVC) to improve learning outcomes of incoming anesthesia residents during procedural simulation training.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 29, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

November 26, 2021

Status Verified

October 1, 2021

Enrollment Period

2 days

First QC Date

October 29, 2021

Last Update Submit

November 24, 2021

Conditions

Keywords

simulationeducationobserver toolcentral venous catheter

Outcome Measures

Primary Outcomes (1)

  • composite score describing acquisition of the CVC procedural skills using a questionnaire immediately after training

    The questionnaire of the composite score includes : 20 knowledge MCQs (/ 20), questions about the perception of practical (0 to 10) and theoretical (0 to 10) improvement of knowledge and skills, perception of the future professional impact of this training (0 to 10) and satisfaction with the training session (0 to 10). All items scored out of 10 will be measured by a Likert scale from 0 to 10.

    10 minutes at the end of the session

Secondary Outcomes (4)

  • question of each item of the composite score

    10 minutes at the end of the session

  • retention using a questionnaire by e-mail (self-report)

    10 minutes at 1 month

  • Evaluation of professional practice using a questionnaire by e-mail (self-report)

    1 minutes during the first month after

  • Evaluation of professional practice using a questionnaire by e-mail (self-report)

    2 minutes during the first month after

Study Arms (2)

group OT +

EXPERIMENTAL

In this group (OT +), the resident will complete an observer tool each time another resident is observed to insert a CVC on the simulator.

Other: observer tool

group OT-

NO INTERVENTION

In this group (OT-), the resident will not use the observer tool and will observe other residents to insert a CVC on the simulator without any physical support.

Interventions

comparison of the efficacy of an observer tool to enhance learning of technical skills of CVC insertion in anesthesiology residents The resident will complete an observer tool each time another resident is observed to insert a CVC on the simulator.

group OT +

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first year anesthesiology residents

You may not qualify if:

  • absence to the CVC training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculté de médecine Paris Sud

Le Kremlin-Bicêtre, 94276, France

Location

Study Officials

  • Antonia Blanié, MD, PhD

    SRP07 UNIVERSITE PARIS-SACLAY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel assignment, not blinded, randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 26, 2021

Study Start

November 2, 2021

Primary Completion

November 4, 2021

Study Completion

December 15, 2021

Last Updated

November 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations