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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Procedure: insertion of a catheter

• Registration Number: NCT03790241
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-28
• Study First Posted: 2018-12-31
• Study Start: 2019-04-25
• Primary Completion: 2020-02-14
• Study Completion: 2020-02-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Needle velocity during perforation measured by a flexible piezoresistive sensor	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	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	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	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.
Punctures forces of the skin and veins measured by an instrumented syringue	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Laboratory of Biomechanics and Impact Mechanics - Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France