Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05134818 |
| Other study ID # |
LabForSims-004 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2, 2021 |
| Est. completion date |
December 15, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Université Paris-Sud |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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 (2). 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.
This prospective and randomized study will be performed in the simulation center of
Paris-Saclay University (LabForSIMS). This training takes place annually at the beginning of
the first six-month rotation during an initial training seminar ("bootcamp"). All incoming
residents (approximately 90 residents / year) participate on a mandatory basis.
Each CVC insertion training session includes a theoretical part carried out in the form of
flipped classroom (sending pedagogical documents upstream) and a practical part on a
simulator. Each practical session (1h30, about 7 residents/1 instructor) is repeated twice
during the half-day. The workshop has three stages: theoretical reminder, supervised practice
on echogenic gelatin to learn needling under ultrasound, then supervised practice on a CVC
simulator (part task chest trainer allowing ultrasound visualization) for the insertion of
CVC. Each resident trains at least once on this simulator and is an observer of the other
training sessions.
After informed consent, residents will be included. Each session will be randomized upstream
by:
- Group with observer tool (OT +) during practical training on a simulator
- Group without observer tool (OT-) The observer tool used will be adapted from a
previously published checklist which includes the main items to be carried out when
inserting a CVC. It will be completed by residents from the OT + group each time another
resident is observed. It will only be used to reinforce learning and will not be used
for summative evaluation.
The primary outcome will be a composite score describing acquisition of the CVC procedural
skills immediately after training by comparing the groups using or not the OT (level 1-2-3 of
the Kirkpatrick model). The composite score (used in one of our previous studies [Blanié A et
al. 2021 submitted]) includes: knowledge MCQs (/ 20), perception of practical (/ 10) and
theoretical (/ 10) improvement of knowledge and skills, perception of the future professional
impact of this training (/ 10) and satisfaction with the training session (/ 10). All items
scored out of 10 will be measured by a Likert scale from 0 to 10.
The secondary outcomes will include separate analysis of each item of the composite score.
Moreover, initial retention will be analyzed at 1 month, using the same items as above.
Evaluation of professional practice will also be recorded by the resident during the 1st
month after the training and will include the number of CVCs placed and for each CVC
insertion via the internal jugular route (for the first 5): the number of punctures, success
or failure, complications (pneumothorax, arterial puncture, others) (level 3 and 4 of the
Kirkpatrick model).
A reminder will be sent every two weeks and a medical book will be offered to each resident
who will have fully completed the questionnaire.
