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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Educational Problems
• Intervention / Treatment: Device: Compuflo Epidural Training Instrument

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• PGY3 trainees who have never performed an epidural block

Exclusion Criteria:

• PGY3 trainees who have already performed an epidural block

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Structured Didactic Model Group; 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; 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.; Other Names: Eye tracking glasses; Standardized educational videorecordings; Epidural Simulator
No Intervention: Standard Training Model; The standard local institutional teaching program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EESOA9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No