NCT03812926

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

January 19, 2019

Last Update Submit

January 22, 2019

Conditions

Epidural Simulator

Outcome Measures

Primary Outcomes (1)

  • epidural attempts

    number of attempts to correctly identify the epidural space

    10 minutes

Interventions

Compuflo assited procedureDEVICE

number of needle entry required to identify the ligamentum flavum

Also known as: Standard assisted procedure

Eligibility Criteria

Age26 Years - 35 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EESOA Maternal Neonatal Simulation Centre

Roma, 00151, Italy

Location

Related Publications (1)

  • 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.

    PMID: 31611917DERIVED

Study Officials

  • Giorgio Capogna

    European e-Learning School in Obstetric Anesthesia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2019

First Posted

January 23, 2019

Study Start

December 1, 2018

Primary Completion

January 20, 2019

Study Completion

January 20, 2019

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)