Skip to main content
OpenTrials
Completed

NCT Number: NCT03790241

In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Biomechanics and Impact Mechanics - Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult volunteer
  • Aged between 18-25 yo or 60-75 yo
  • IBM between 18,5-25 or superior or equal to 30
  • Cognitive level compatible with oral communication, respect of safety instructions and understanding of realized acts
  • Signed the study agreement

Exclusion criteria

  • Individuals displaying coagulation disorders
  • Individuals displaying skin lesions, scars or areteriovenous fistula on the ventral side of the forearm
  • Individuals displaying a high infection risk
  • Women that have been subject to a lymph node dissection on a malignant breast tumor
  • Individuals not able to express their consent
  • Individuals having a hierarchical link with the persons conducting this study
  • Individuals currently participating to another research which includes an exclusion period

Treatment and study plan

insertion of a catheter

Procedure

Analysis 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

Primary outcomes

  1. Punctures forces of the skin and veins measured by an instrumented syringue

    Time frame: Day 0 (at intervention)

    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.

  2. Needle velocity during perforation measured by a flexible piezoresistive sensor

    Time frame: Day 0

    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.

  3. Needle insertion angle during perforation measured by digital image correlation

    Time frame: Day 0

    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.

  4. Loads applied by the palpating finger to locate the vein to puncture, measured by digital image correlation

    Time frame: Day 0

    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.

  5. Spatial displacement of the palpating finger measured by digital image correlation

    Time frame: Day 0

    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.

Secondary outcomes

  1. Age

    Time frame: Day 0

    to evaluate the Influence of age regarding the puncture forces

  2. Sex

    Time frame: Day 0

    to evaluate the Influence of sex regarding the puncture forces

  3. Weight

    Time frame: Day 0

    to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces

  4. Height

    Time frame: Day 0

    to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ABGPVVP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 31, 2018
Registry last updated
Sep 17, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.