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Achieving Lumbar Epidural Block Competency in Inexperienced Trainees After a Structured Teaching Model

NCT04749186 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-03-23

No results posted yet for this study

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, 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.

Conditions

  • Educational Problems

Interventions

DEVICE

Compuflo Epidural Training Instrument

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    collaborator OTHER

  • European e-Learning School in Obstetric Anesthesia

    lead OTHER

Principal Investigators

  • Giorgio Capogna, MD · European e-Learning School in Obstetric Anesthesia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749186 on ClinicalTrials.gov