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

Healthy Clinical Trial

— ABGPVVP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790241
• Other study ID #: 69HCL18_0533
• Secondary ID: 2018-A02895-50
• Status: Completed
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: February 14, 2020

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 14, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
France	Laboratory of Biomechanics and Impact Mechanics - Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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	Age	to evaluate the Influence of age regarding the puncture forces	Day 0
Secondary	Sex	to evaluate the Influence of sex regarding the puncture forces	Day 0
Secondary	Weight	to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces	Day 0
Secondary	Height	to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces	Day 0