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Status unknownNCT05134818Updated Nov 26, 2021

Observer Tool Use and Learning Outcomes for Central Venous Catheter Insertion Training

An interventional study of observer tool in Education and Simulation, sponsored by Université Paris-Sud. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-26.

Sponsored by Université Paris-Sud · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Education
  • Simulation

Keywords

  • simulation
  • education
  • observer tool
  • central venous catheter
03

In context

Lead sponsor

Université Paris-Sud is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • first year anesthesiology residents

Exclusion criteria

Exclusion Criteria:

  • absence to the CVC training
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    group OT +

    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

  • No intervention
    group OT-

    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

  • Otherobserver tool

    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.

06

What researchers measure

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.

    Time frame: 10 minutes at the end of the session

Secondary outcomes

  1. question of each item of the composite score

    Separate analysis of each question of the composite score: knowledge MCQs (/ 20), 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).

    Time frame: 10 minutes at the end of the session

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

    initial retention analyzed at 1 month, using the same questionnaire as above (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)

    Time frame: 10 minutes at 1 month

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

    Evaluation of professional practice will also be recorded by the resident during the 1st month after the training using a questionnaire send by e-mail (self-report) (level 3 and 4 of the Kirkpatrick model). It will include a question of the number of CVCs placed (0 to \>10).

    Time frame: 1 minutes during the first month after

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

    Evaluation of professional practice will also be recorded by the resident during the 1st month after the training using a questionnaire send by e-mail (self-report) (level 3 and 4 of the Kirkpatrick model). It will include questions for each CVC insertion via the internal jugular route (for the first 5) about the number of punctures (0 to \>10), success or failure, complications (pneumothorax, arterial puncture, others) (Yes or No)

    Time frame: 2 minutes during the first month after

07

Study locations

1 site
  • Faculté de médecine Paris Sud
    Le Kremlin-Bicêtre, 94276, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05134818
Lead sponsor
Université Paris-Sud
Responsible party
Sponsor
First posted
Nov 26, 2021
Start date
Nov 2, 2021
Primary completion
Nov 4, 2021
Completion
Dec 15, 2021 (estimated)
Last update
Nov 26, 2021

Study contacts

Antonia Blanié, MD, PhD
principal investigator · SRP07 UNIVERSITE PARIS-SACLAY

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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