Compuflo® vs Conventional Training With an Epidural Simulator

Compuflo® Assisted Training vs Conventional Training for the Identification of the Ligamentum Flavum With an Epidural Simulator

Epidural block is one of the most difficult skills that can be mastered by trainees probably due to the difficulty of recognizing the ligamentum flavum (LF) during the loss of resistance technique (LORT).The CompuFlo® Instrument can measure the pressure of human tissues in real-time at the orifice of a needle and it has been successfully used in clinical practice to identify the epidural space.The aim of this study was to evaluate whether Compuflo® may help trainees to identify the ligamentum flavum using a realistic Epidural Simulator

Study Overview

• Status: Completed
• Conditions: Epidural Simulator
• Intervention / Treatment: Device: Compuflo assited procedure

Detailed Description

The investigators enrolled 60 trainees who have never performed an epidural block. After having had a standardized learning module on epidural anatomy and technique, each trainee practiced the epidural and the Compuflo®-assisted LORT on the simulator for a maximum of 5 attemps. Trainees were asked to stop the needle entrance whenever they felt a sensation of an increase of resistance due to the penetration of the needle in the LF. The correct position of the needle was verified by an expert instructor. The number of attempts was noted. The power analysis required a sample size of 60 observations to set 80% test power and a 95% significance. Unpaired T-test was used to evaluate the differences in the number of epidural attempts. A logistic regression model was used to correlate the "success at the first attempt ratio" and the technique used.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00151
    • EESOA Maternal Neonatal Simulation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 35 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

First year trainees in anesthesia who never have performed an epidural block

Description

Inclusion Criteria:

First year trainees in anesthesia who never have performed an epidural block

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
epidural attempts	number of attempts to correctly identify the epidural space	10 minutes

Collaborators and Investigators

• Sponsor: European e-Learning School in Obstetric Anesthesia
• Investigators: Study Director: Giorgio Capogna, European e-Learning School in Obstetric Anesthesia

Publications and helpful links

General Publications

• Capogna E, Coccoluto A, Gibiino G, Del Vecchio A. Compuflo(R)-Assisted Training vs Conventional Training for the Identification of the Ligamentum Flavum with an Epidural Simulator: A Brief Report. Anesthesiol Res Pract. 2019 Sep 12;2019:3804743. doi: 10.1155/2019/3804743. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): January 20, 2019
• Study Completion (Actual): January 20, 2019

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: January 19, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: EESOA1

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