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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03790241
Acronym
ABGPVVP
Enrollment
31
Registered
2018-12-31
Start date
2019-04-25
Completion date
2020-02-14
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

catheter insertion, puncture, skin, vein, palpation, motion tracking

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.

Interventions

PROCEDUREinsertion 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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Spatial displacement of the palpating finger measured by digital image correlationDay 0obtained 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.
Punctures forces of the skin and veins measured by an instrumented syringueDay 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.
Needle velocity during perforation measured by a flexible piezoresistive sensorDay 0In 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.
Needle insertion angle during perforation measured by digital image correlationDay 0obtained 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.
Loads applied by the palpating finger to locate the vein to puncture, measured by digital image correlationDay 0obtained 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

MeasureTime frameDescription
SexDay 0to evaluate the Influence of sex regarding the puncture forces
WeightDay 0to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces
HeightDay 0to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces
AgeDay 0to evaluate the Influence of age regarding the puncture forces

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026