Compuflo® vs Conventional Training 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

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Key information

Conditions

Epidural Simulator

Age range

26 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

EESOA Maternal Neonatal Simulation Centre

Roma, 00151, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Compuflo assited procedure

Device

number of needle entry required to identify the ligamentum flavum

Other names: Standard assisted procedure

Primary outcomes

epidural attempts

Time frame: 10 minutes

number of attempts to correctly identify the epidural space

Sponsors and collaborators

Lead sponsor

European e-Learning School in Obstetric Anesthesia

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jan 23, 2019
Registry last updated: Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.