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EducationNCT05134818

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

A study testing observer tool in people with Education and Simulation, run by Université Paris-Sud at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Education, Simulation
What is being tested?
observer tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteFrance
Study dates
2 Nov 2021to 15 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • first year anesthesiology residents

Who cannot join

  • absence to the CVC training

Trial locations and contacts

1 site in 1 country.

France1 site
  • Faculté de médecine Paris Sud

    Le Kremlin-Bicêtre, 94276

Other trials in France

About this study

Official title: Use of an Observer Tool to Improve Learning Outcomes of Incoming Anesthesia Residents During Procedural Simulation Training of Central Venous Catheter Insertion: a Randomized Controlled Trial of Simulation Training

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.

Being tested
observer tool
Keywords
simulation, education, observer tool, central venous catheter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observer toolOther

    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.

Study groups in NCT05134818
Study groupRoleWhat they receive
group OT +ExperimentalIn this group (OT +), the resident will complete an observer tool each time another resident is observed to insert a CVC on the simulator.
Receives: Other: observer tool
group OT-No interventionIn 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 10 minutes at the end of the session

Secondary outcomes (4)
  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).

    Measured: 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)

    Measured: 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).

    Measured: 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)

    Measured: 2 minutes during the first month after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2021
  2. Study start2 Nov 2021
  3. Primary completion4 Nov 2021
  4. Study completion15 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment, not blinded, randomized study
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05134818
Sponsor's protocol ID
LabForSims-004
Status last verified
Oct 2021
First submitted
29 Oct 2021
Last updated
26 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing observer tool in people with Education and Simulation, run by Université Paris-Sud at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite score describing acquisition of the CVC procedural skills using a questionnaire immediately after training (time frame: 10 minutes at the end of the session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.

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