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.
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.
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.
- Conditions
- Education, Simulation
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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.
- First posted26 Nov 2021
- Study start2 Nov 2021
- Primary completion4 Nov 2021
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Université Paris-Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Blanié, MD, PhD, Principal investigator, SRP07 UNIVERSITE PARIS-SACLAY
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05134818
- Acronym / sponsor ID
- LabForSims-004
- Conditions
- Education, Simulation
- Keywords
- simulation, education, observer tool, central venous catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Université Paris-SudUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment, not blinded, randomized study
| Arm | Type | Receives |
|---|---|---|
| group OT + | Experimental | Other: observer toolIn this group (OT +), the resident will complete an observer tool each time another resident is observed to insert a CVC on the simulator. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- first year anesthesiology residents
Key exclusion criteria (1 listed)
- absence to the CVC training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observer toolcomparison 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. | Other | group OT + |
Primary outcome
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
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.
4 secondary outcomes
question of each item of the composite score
Time frame: 10 minutes at the end of the session
retention using a questionnaire by e-mail (self-report)
Time frame: 10 minutes at 1 month
Evaluation of professional practice using a questionnaire by e-mail (self-report)
Time frame: 1 minutes during the first month after
Evaluation of professional practice using a questionnaire by e-mail (self-report)
Time frame: 2 minutes during the first month after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia Blanié, MD, PhD principal investigator
SRP07 UNIVERSITE PARIS-SACLAY
1 site in 1 country: see every site and its status.
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.