SYMPA-VEIN : Pilot Study Evaluating the ACCUVEIN Superficial Vein Visualization Device for the Detection of Alterations in the Autonomic Nervous System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Progressive standing test
研究概览
简要总结
Dysautonomia is an alteration of the autonomic nervous system that manifests itself in different forms, some of which are very disabling. Dysautonomia accompanies many pathologies. Its importance in public health is illustrated by an incidence of 20-70% in diabetes. It affects between 400,000 and 1.4 million patients in the French diabetic population alone. Dysautonomia is mainly investigated through alterations in the cardiovascular system's reactivity to various maneuvers. It involves a methodology that evaluates the functionality of the sympathetic nervous system. This methodology is reserved for specialized laboratories, limiting access to diagnosis. Dysautonomia is therefore commonly overlooked for lack of a simple, effective diagnostic tool.
ACCUVEIN is an augmented-reality venipuncture device. It projects the network of superficial veins onto the patient's skin. Our aim is to show that ACCUVEIN is capable of objectivizing the venoconstriction caused by activation of the sympathetic system in a healthy subject, such as when moving to a standing position. If ACCUVEIN has this capability, it would then represent a simple and rapid diagnostic tool for objectifying a venoconstriction defect in patients with dysautonomia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects between the ages of 18 and 40
- •Subject affiliated with or benefiting from a social security plan
- •Subject having signed an informed consent form
- •Subject without known chronic illness or long-term treatment (oral contraceptive authorized for women)
- •Subject without symptoms of dysautonomia
- •Subject with no history of cardiovascular disease
- •No history of loss of consciousness
- •Subjects without regular and excessive alcohol consumption according to the WHO
- •Non-smoker, non-vapoteur
- •No chronic pain
排除标准
- •Known ECG abnormality
- •Pregnant women, parturients and nursing mothers
- •Person deprived of liberty by administrative or judicial decision
- •Person under compulsory psychiatric care
- •Adult subject to a legal protection measure
- •Persons unable to express their consent
- •Subject unable to understand study objectives or instructions
- •Subject in a period of exclusion from another study
结局指标
主要结局
Progressive standing test
时间窗: Day 1
If the subject's resting ECG is normal, the experimental session then begins with a progressive uprighting test of the subject in increments starting at 0° (the horizontal position) then moving on to 15°, then 30°, then 45° and finally 70°, the maximum upright head-up position, i.e. a total of 5 increments). Progressive verticalization is performed on a verticalization table used in standard autonomic nervous system assessment procedures. Three thoracic electrocardiographic electrodes and the blood pressure measurement finger pad on the right middle finger are positioned, then the left upper limb is stripped and held at heart level by a suitable support throughout the experimental procedure. The subject then lies down on the examination table. Each level is maintained for 5 minutes. At the end of the last 70° stop, the examination table is returned to the horizontal position.
次要结局
- Blood pressure recording(Day 1)
- Heart rate recording(Day 1)
- ACCUVEIN(Day 1)
- Breathing test(Day 1)