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

NCT04749186 | Unknown

• 1 other identifier: EESOA9
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  20 minutes after the epidural procedure

Study Arms (2)

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.

Device: Compuflo Epidural Training Instrument

Standard Training Model

NO INTERVENTION

The standard local institutional teaching program

Interventions

Compuflo Epidural Training Instrument DEVICE

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.

Also known as: Eye tracking glasses, Standardized educational videorecordings, Epidural Simulator

Structured Didactic Model Group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• PGY3 trainees who have never performed an epidural block

You may not qualify if:

• PGY3 trainees who have already performed an epidural block

Sponsors & Collaborators

• European e-Learning School in Obstetric Anesthesia: lead
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

Location

Study Officials

• Giorgio Capogna, MD

  European e-Learning School in Obstetric Anesthesia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 11, 2021
• Study Start: April 7, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: March 23, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)