HealthyABGPVVPNCT03790241
In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion
A study testing insertion of a catheter in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- insertion of a catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2019to 14 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Laboratory of Biomechanics and Impact Mechanics - Centre Hospitalier Lyon Sud
Pierre-Bénite
About this study
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.
- Conditions
- Healthy
- Being tested
- insertion of a catheter
- Keywords
- catheter insertion, puncture, skin, vein, palpation, motion tracking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insertion of a catheterProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Young males of normal corpulence | Experimental | Insertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25 Receives: Procedure: insertion of a catheter |
| Young females of normal corpulence | Experimental | Insertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25 Receives: Procedure: insertion of a catheter |
| Aged males of normal corpulence | Experimental | Insertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25 Receives: Procedure: insertion of a catheter |
| Aged females of normal corpulence | Experimental | Insertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25 Receives: Procedure: insertion of a catheter |
| Obese young males | Experimental | Insertion of a catheter to people ageg between 18 and 25; superior or equal to 30 Receives: Procedure: insertion of a catheter |
| Obese young females | Experimental | Insertion of a catheter to people ageg between 18 and 25; superior or equal to 30 Receives: Procedure: insertion of a catheter |
| Obese aged males | Experimental | Insertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30 Receives: Procedure: insertion of a catheter |
| Obese aged females | Experimental | Insertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30 Receives: Procedure: insertion of a catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Secondary outcomes (4)
Age
to evaluate the Influence of age regarding the puncture forces
Measured: Day 0
Sex
to evaluate the Influence of sex regarding the puncture forces
Measured: Day 0
Weight
to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces
Measured: Day 0
Height
to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start25 Apr 2019
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790241
- Sponsor's protocol ID
- 69HCL18_0533
- Other IDs
- 2018-A02895-50
- Acronym
- ABGPVVP
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2018
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33781485
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion
- ClinicalTrials.gov ID
- NCT03790241
- Acronym / sponsor ID
- ABGPVVP / 69HCL18_0533
- Conditions
- Healthy
- Keywords
- catheter insertion, puncture, skin, vein, palpation, motion tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Young males of normal corpulence | Experimental | Procedure: insertion of a catheterInsertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25 |
| Young females of normal corpulence | Experimental | Procedure: insertion of a catheterInsertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25 |
| Aged males of normal corpulence | Experimental | Procedure: insertion of a catheterInsertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25 |
| Aged females of normal corpulence | Experimental | Procedure: insertion of a catheterInsertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25 |
| Obese young males | Experimental | Procedure: insertion of a catheterInsertion of a catheter to people ageg between 18 and 25; superior or equal to 30 |
| Obese young females | Experimental | Procedure: insertion of a catheterInsertion of a catheter to people ageg between 18 and 25; superior or equal to 30 |
| Obese aged males | Experimental | Procedure: insertion of a catheterInsertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30 |
| Obese aged females | Experimental | Procedure: insertion of a catheterInsertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insertion of a catheterAnalysis 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 | Procedure or surgery | Aged females of normal corpulence, Aged males of normal corpulence, Obese aged females, Obese aged males, Obese young females, Obese young males, Young females of normal corpulence, Young males of normal corpulence |
Primary outcome
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.
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.
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.
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.
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.
4 secondary outcomes
Age
Time frame: Day 0
Sex
Time frame: Day 0
Weight
Time frame: Day 0
Height
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Results publication: PubMed 33781485Torossian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insertion of a catheter in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Punctures forces of the skin and veins measured by an instrumented syringue (time frame: Day 0 (at intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03790241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.