In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Needle insertion angle during perforation measured by digital image correlation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Young males of normal corpulence
Insertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25
干预措施: insertion of a catheter (Procedure)
Young females of normal corpulence
Insertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25
干预措施: insertion of a catheter (Procedure)
Aged males of normal corpulence
Insertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25
干预措施: insertion of a catheter (Procedure)
Aged females of normal corpulence
Insertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25
干预措施: insertion of a catheter (Procedure)
Obese young males
Insertion of a catheter to people ageg between 18 and 25; superior or equal to 30
干预措施: insertion of a catheter (Procedure)
Obese young females
Insertion of a catheter to people ageg between 18 and 25; superior or equal to 30
干预措施: insertion of a catheter (Procedure)
Obese aged males
Insertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30
干预措施: insertion of a catheter (Procedure)
Obese aged females
Insertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30
干预措施: insertion of a catheter (Procedure)
结局指标
主要结局
Needle insertion angle during perforation measured by digital image correlation
时间窗: 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
时间窗: 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
时间窗: 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.
Needle velocity during perforation measured by a flexible piezoresistive sensor
时间窗: 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.
Punctures forces of the skin and veins measured by an instrumented syringue
时间窗: 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.
次要结局
- Age(Day 0)
- Sex(Day 0)
- Weight(Day 0)
- Height(Day 0)