Compuflo® vs Conventional Training With an Epidural Simulator

Epidural Simulator Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812926
• Other study ID #: EESOA1
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: January 20, 2019

Study information

• Verified date: January 2019
• Source: European e-Learning School in Obstetric Anesthesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 20, 2019
• Est. primary completion date: January 20, 2019
• Gender: All
• Age group: 26 Years to 35 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Epidural Simulator

Intervention

Device:
• Compuflo assited procedure
number of needle entry required to identify the ligamentum flavum

Locations

Country	Name	City	State
Italy	EESOA Maternal Neonatal Simulation Centre	Roma

Sponsors (1)

Lead Sponsor	Collaborator
European e-Learning School in Obstetric Anesthesia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epidural attempts	number of attempts to correctly identify the epidural space	10 minutes