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

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Civil Hospices of Lyon

Status

Completed

Conditions

Healthy

Treatments

Procedure: insertion of a catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT03790241
2018-A02895-50 (Other Identifier)
69HCL18_0533

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

31 participants in 8 patient groups

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

Trial contacts and locations

1

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Central trial contact

Kevin Torossian; Anthony Viste

Data sourced from clinicaltrials.gov

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