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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: insertion of a catheter

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France
    • Laboratory of Biomechanics and Impact Mechanics - Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Young males of normal corpulence; Insertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25	Procedure: insertion of a catheter; 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
Experimental: Young females of normal corpulence; Insertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25	Procedure: insertion of a catheter; 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
Experimental: Aged males of normal corpulence; Insertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25	Procedure: insertion of a catheter; 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
Experimental: Aged females of normal corpulence; Insertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25	Procedure: insertion of a catheter; 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
Experimental: Obese young males; Insertion of a catheter to people ageg between 18 and 25; superior or equal to 30	Procedure: insertion of a catheter; 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
Experimental: Obese young females; Insertion of a catheter to people ageg between 18 and 25; superior or equal to 30	Procedure: insertion of a catheter; 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
Experimental: Obese aged males; Insertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30	Procedure: insertion of a catheter; 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
Experimental: Obese aged females; Insertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30	Procedure: insertion of a catheter; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	to evaluate the Influence of age regarding the puncture forces	Day 0
Sex	to evaluate the Influence of sex regarding the puncture forces	Day 0
Weight	to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces	Day 0
Height	to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces	Day 0

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• Torossian K, Ottenio M, Brulez AC, Lafon Y, Viste A, Attali P, Benayoun S. Biomechanical analysis of practitioner's gesture for peripheral venous catheter insertion. Med Eng Phys. 2021 Apr;90:92-99. doi: 10.1016/j.medengphy.2021.03.001. Epub 2021 Mar 4.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Actual): February 14, 2020
• Study Completion (Actual): February 14, 2020

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (Actual): December 31, 2018

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: skin; puncture; catheter insertion; vein; palpation; motion tracking
• Other Study ID Numbers: 69HCL18_0533; 2018-A02895-50 (Other Identifier: ANSM Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No