In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion (ABGPVVP)
September 11, 2025 updated by: Hospices Civils de Lyon
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
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pierre-Bénite, France
- Laboratory of Biomechanics and Impact Mechanics - Centre Hospitalier Lyon Sud
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
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. |
Day 0 (at intervention)
|
|
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. |
Day 0
|
|
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.
|
Day 0
|
|
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.
|
Day 0
|
|
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.
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: Day 0
|
to evaluate the Influence of age regarding the puncture forces
|
Day 0
|
|
Sex
Time Frame: Day 0
|
to evaluate the Influence of sex regarding the puncture forces
|
Day 0
|
|
Weight
Time Frame: Day 0
|
to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces
|
Day 0
|
|
Height
Time Frame: Day 0
|
to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.