Brief Summary

The aim of this study is to analyze the palpation and perforation motion performed by the practitioner during the insertion of a catheter while measuring the loads applied on the skin and the veins. These experimental measures will be used for the design of a more realistic peripheral venous catheter insertion simulator in order to better prepare healthcare students for their first in vivo venous puncture.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline

Completed

Started Apr 2019

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

10 months study duration

First Submitted

Initial submission to the registry

December 6, 2018

Completed

25 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed

4 months until next milestone

Study Start

First participant enrolled

April 25, 2019

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2020

Completed

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

December 6, 2018

Last Update Submit

September 11, 2025

Conditions

Healthy

Keywords

catheter insertionpunctureskinveinpalpationmotion tracking

Outcome Measures

Primary Outcomes (5)

Punctures forces of the skin and veins measured by an instrumented syringue
According to the literature, puncture forces of soft tissues are decomposed as a summation of stiffness forces, friction forces and cutting forces. In the case of this study, an instrumented syringe has been designed to measure the puncture force in function of time. This device includes a miniature1-axis load sensor. The catheters can be easily removed thanks to a conical fitting which is directly connected to the load sensor to obtain the forces when inserting and withdrawing the catheter. The primary sought measures are the peak force occurring when penetrating the skin and the vein as well as the friction forces when withdrawing the catheter from the vein.
Day 0 (at intervention)
Needle velocity during perforation measured by a flexible piezoresistive sensor
In order to obtain the load applied by the practitioner to locate the vein to puncture, a flexible piezoresistive sensor is placed to the practitioner's fingertip with double side tape The sensor is linked to its acquisition module which is connected via Wi-Fi to a computer. In order to not disturb the motion of the practitioner, the module if fixed with a sport armband to the forearm. The primary sought measure is the curve force in function of time.
Day 0
Needle insertion angle during perforation measured by digital image correlation
obtained thanks to digital image correlation which consists of tracking sights with two high speed cameras. Thus, sights will be placed on the side of the palpating finger and instrumented syringe.
Day 0
Loads applied by the palpating finger to locate the vein to puncture, measured by digital image correlation
obtained thanks to digital image correlation which consists of tracking sights with two high speed cameras. Thus, sights will be placed on the side of the palpating finger and instrumented syringe.
Day 0
Spatial displacement of the palpating finger measured by digital image correlation
obtained thanks to digital image correlation which consists of tracking sights with two high speed cameras. Thus, sights will be placed on the side of the palpating finger and instrumented syringe.
Day 0

Secondary Outcomes (4)

Age
Day 0
Sex
Day 0
Weight
Day 0
Height
Day 0