Educational ProblemsNCT04749186
Achieving Lumbar Epidural Block Competency in Inexperienced Trainees After a Structured Teaching Model
A study testing Compuflo Epidural Training Instrument in people with Educational Problems, run by European e-Learning School in Obstetric Anesthesia at 1 site in Italy.
Trial summary
There is currently no universally accepted, comprehensive, or standard systematic way to teach the epidural block. Typical teaching of epidural catheter placement consists of a combination of didactic education and hands-on experience, where apprentice and master approached the task together in the clinical setting… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- Compuflo Epidural Training Instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 7 Apr 2021to 30 Sep 2022
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- PGY3 trainees who have never performed an epidural block
Who cannot join
- PGY3 trainees who have already performed an epidural block
Trial locations and contacts
1 site in 1 country.
About this study
There is currently no universally accepted, comprehensive, or standard systematic way to teach the epidural block. Typical teaching of epidural catheter placement consists of a combination of didactic education and hands-on experience, where apprentice and master approached the task together in the clinical setting, with live patients as the learning model.
The learning curve is one of the most common tools to assess how the physician in training is progressing at a skill, and it is defined as a curve generated by plotting the success or failure against the number of attempts. More complex learning curves using an acceptable and unacceptable failure rate can be constructed. To perform these more complex learning curves a statistical tool such as the Cumulative Sum Technique (CUSUM) may be used.
Read more
The CompuFlo Epidural Trainer can differentiate tissue types by pressure signatures that are imperceptible to touch. This allows the trainee to accurately identify the needle location and discriminate between false and true loss of resistance. Having displayed, recorded and printed a graph illustrating the procedure, may also lead to a greater appreciation of the anatomy of the structures the needle must pass.
Eye-tracking is the process of measuring either the point of gaze or the motion of an eye relative to the head. This method has been successfully used for proficiency assessment.
The aim of this study will be to investigate whether the use of a Structured Didactic Model (SDM) including standardized video lessons, construction of a 3D epidural module, practical training by using an epidural simulator with CompuFlo Trainer instrument, eye tracking assisted technique, may affect the CUSUM learning curve for lumbar epidural block in novice, inexperienced trainees and their eye-tracking patterns.
Read the detailed description
Researchers will enroll 15 PGY3 trainees who have never performed an epidural block and are about to begin their obstetrics rotation. After having had the usual standard front-lecture on anatomy and technique, they will be randomized into two groups to receive (study group) or to not receive (control group) the additional SDM (Structured Didactic Model). The additional SDM will consist in two standardized video lessons (anatomy and technique), construction of a 3D epidural plastic module, practical training by using an epidural simulator with the CompuFlo Trainer instrument, and practical training with the eye-tracking assisted technique.
After the randomization and before their practice on the patients, all the trainees will undergo eye-tracking measurement of their visual patterns while performing the epidural block on an epidural simulator.
All trainees will perform lumbar epidural anesthesia under the supervision of their instructors in accordance with local Institutional policy and practice, with the standard routine equipment and monitoring. Every time the trainee will perform an epidural technique, the number of attempts, needle redirections, and effectiveness of the epidural block will be noted and used to construct the corresponding CUSUM curve.
When enough epidurals will be performed by each trainee to reach competence according to the CUSUM curve, a post hoc Power Analysis will be carried out to verify the 95% significance level and the 80 % test power. To study and compare the evolution of the success rate in each group a linear regression model will be applied.
- Conditions
- Educational Problems
- Being tested
- Compuflo Epidural Training Instrument
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compuflo Epidural Training InstrumentDevice
Also called Eye tracking glasses, Standardized educational videorecordings, Epidural Simulator
The intervention will consist of a Structured Didactic Model. It will include the following: two standardized video lessons (anatomy and technique), construction of a 3D epidural plastic module, practical training by using an epidural simulator with the CompuFlo Trainer instrument, and practical training with the eye-tracking assisted technique.
| Study group | Role | What they receive |
|---|---|---|
| Structured Didactic Model Group | Active comparator | A standardized video lessons (anatomy and technique), construction of a 3D epidural plastic module, practical training by using an epidural simulator with the CompuFlo Trainer instrument, and practical training with the eye-tracking assisted technique. Receives: Device: Compuflo Epidural Training Instrument |
| Standard Training Model | No intervention | The standard local institutional teaching program |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of attempts
Every time the trainee will perform an epidural technique, a number of attempts will be noted and used to construct the corresponding CUSUM learning curve.
Measured: immediately after the procedure
number of needle redirections
Every time the trainee will perform an epidural technique, a number of needle redirections will be noted and used to construct the corresponding CUSUM learning curve.
Measured: immediately after the procedure
efficacy of epidural block
The efficacy of the epidural block will be evaluated by using a visual analogue pain scale where 0=no pain-100=worst pain
Measured: 20 minutes after the epidural procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start7 Apr 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European e-Learning School in Obstetric Anesthesia
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Responsible party
- Sponsor
- Investigators
- Giorgio Capogna, MD, Study director, European e-Learning School in Obstetric Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749186
- Sponsor's protocol ID
- EESOA9
- Status last verified
- Apr 2021
- First submitted
- 4 Feb 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- 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 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Lumbar Epidural Block Competency in Inexperienced Trainees After a Structured Teaching Model
- ClinicalTrials.gov ID
- NCT04749186
- Acronym / sponsor ID
- EESOA9
- Conditions
- Educational Problems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- European e-Learning School in Obstetric AnesthesiaUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 11 Feb 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.
There is currently no universally accepted, comprehensive, or standard systematic way to teach the epidural block. Typical teaching of epidural catheter placement consists of a combination of didactic education and hands-on experience, where apprentice and master approached the task together in the clinical setting, with live patients as the learning model.
The learning curve is one of the most common tools to assess how the physician in training is progressing at a skill, and it is defined as a curve generated by plotting the success or failure against the number of attempts. More complex learning curves using an acceptable and unacceptable failure rate can be constructed. To perform these more complex learning curves a statistical tool such as the Cumulative Sum Technique (CUSUM) may be used.
The CompuFlo Epidural Trainer can differentiate tissue types by pressure signatures that are imperceptible to touch. This allows the trainee to accurately identify the needle location and discriminate between false and true loss of resistance. Having displayed, recorded and printed a graph illustrating the procedure, may also lead to a greater appreciation of the anatomy of the structures the needle must pass.
Eye-tracking is the process of measuring either the point of gaze or the motion of an eye relative to the head. This method has been successfully used for proficiency assessment.
The aim of this study will be to investigate whether the use of a Structured Didactic Model (SDM) including standardized video lessons, construction of a 3D epidural module, practical training by using an epidural simulator with CompuFlo Trainer instrument, eye tracking assisted technique, may affect the CUSUM learning curve for lumbar epidural block in novice, inexperienced trainees and their eye-tracking patterns.
Detailed description
Researchers will enroll 15 PGY3 trainees who have never performed an epidural block and are about to begin their obstetrics rotation. After having had the usual standard front-lecture on anatomy and technique, they will be randomized into two groups to receive (study group) or to not receive (control group) the additional SDM (Structured Didactic Model). The additional SDM will consist in two standardized video lessons (anatomy and technique), construction of a 3D epidural plastic module, practical training by using an epidural simulator with the CompuFlo Trainer instrument, and practical training with the eye-tracking assisted technique.
After the randomization and before their practice on the patients, all the trainees will undergo eye-tracking measurement of their visual patterns while performing the epidural block on an epidural simulator.
All trainees will perform lumbar epidural anesthesia under the supervision of their instructors in accordance with local Institutional policy and practice, with the standard routine equipment and monitoring. Every time the trainee will perform an epidural technique, the number of attempts, needle redirections, and effectiveness of the epidural block will be noted and used to construct the corresponding CUSUM curve.
When enough epidurals will be performed by each trainee to reach competence according to the CUSUM curve, a post hoc Power Analysis will be carried out to verify the 95% significance level and the 80 % test power. To study and compare the evolution of the success rate in each group a linear regression model will be applied.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Didactic Model Group | Active comparator | Device: Compuflo Epidural Training InstrumentA standardized video lessons (anatomy and technique), construction of a 3D epidural plastic module, practical training by using an epidural simulator with the CompuFlo Trainer instrument, and practical training with the eye-tracking assisted technique. |
| Standard Training Model | No intervention | –The standard local institutional teaching program |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- PGY3 trainees who have never performed an epidural block
Key exclusion criteria (1 listed)
- PGY3 trainees who have already performed an epidural block
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 |
|---|---|---|
| Compuflo Epidural Training InstrumentAlso: Eye tracking glasses, Standardized educational videorecordings, Epidural SimulatorThe intervention will consist of a Structured Didactic Model. It will include the following: two standardized video lessons (anatomy and technique), construction of a 3D epidural plastic module, practical training by using an epidural simulator with the CompuFlo Trainer instrument, and practical training with the eye-tracking assisted technique. | Device | Structured Didactic Model Group |
Primary outcome
number of attempts
Time frame: immediately after the procedure
Every time the trainee will perform an epidural technique, a number of attempts will be noted and used to construct the corresponding CUSUM learning curve.
number of needle redirections
Time frame: immediately after the procedure
Every time the trainee will perform an epidural technique, a number of needle redirections will be noted and used to construct the corresponding CUSUM learning curve.
efficacy of epidural block
Time frame: 20 minutes after the epidural procedure
The efficacy of the epidural block will be evaluated by using a visual analogue pain scale where 0=no pain-100=worst pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- 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.
Giorgio Capogna, MD study director
European e-Learning School in Obstetric Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compuflo Epidural Training Instrument in people with Educational Problems, run by European e-Learning School in Obstetric Anesthesia at 1 site in Italy.
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 23 Mar 2022. 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 Italy. 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?
number of attempts (time frame: immediately after the procedure). The study lists 3 primary outcomes in all. 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 23 Mar 2022.