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临床试验/NCT03210857
NCT03210857已完成不适用

Effect of Voluntary Neck Extension in the Occurrence of an Increase in the Pulsatility Index of Right Internal Carotid Artery in the Amateur Diver, Performing an Apnoea of Two Minutes or More: a Prospective, Monocentric, Open Interventional Study

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Effect of the voluntary neck extension in the occurrence of an increase in the pulsatility index of the right internal carotid artery in the amateur diver, realizing an apnea of two minutes or more

研究概览

简要总结

The aim of this study is to demonstrate the effect of the voluntary neck extension in the occurrence of an increase in the pulsatility index of the right internal carotid artery in the amateur diver, realizing an apnea of two minutes or more.

详细描述

In literature concerning apnoea, accidents have been described during neck extension.

Accidental drowning are frequent on the French coast every year and many of them concern apneists victims of apnoeic blackout.

Neck extension is thus suspected to possibly produce an apnoeic blackout at the end of the dive since 1965, when Sir Sciarli (diving medicine pioneer) suspected this hypothesis.

Physiologically, during a dive in apnea, the human cardiovascular system is subjected to a parasympathetic dominance, via the apnea reflex and the diving reflex. This parasympathetic dominant could be reinforced during a neck extension at the end of snorkeling during the ascent.

Hypothesis

the neck extension at the end of apnea contributes to increase the pulsatility index of the right internal carotid artery by vagal component and thus causes a decrease in cerebral blood flow and may lead to the initiation of syncope in the healthy amateur free diver or underwater fisherman.

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 51 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Major (≥18 years), under the age of 51
  • Can hold an apnea of 2 minutes or more
  • Practicing for less than 2 years the apnea at the rate of at least 10 sessions of apnea in the year
  • Not having a known cardiovascular history : any form of heart rhythm disorder, Ischemic heart disease, angina, arteriopathy, any valvular pathology, high blood pressure ...
  • No known respiratory history (asthma, Chronic Obstructive Pulmonary Disease, bronchiectasis, pulmonary emphysema, pneumothorax, pleurisy, pulmonary infection, lobectomy ...)
  • No neurological history of type: epilepsy, deficit syndrome, iterative loss of knowledge, recent head trauma with loss of consciousness

排除标准

  • - Minors and persons over 51 years of age
  • Person under curators or trusteeship
  • Person with a history of cardiovascular, respiratory or epilepsy as cited by the French Federation of Study and Submarine Sports, which poses as a contra-indication to the practice of apnea: Cardiac insufficiency, Obstructive Cardiomyopathy, syncopal risk pathology (valvulopathies type aorting narrowing or mitral narrowing), paroxysmal tachycardia, non-paired auriculo ventricular block 2/3, stroke, uncontrolled hypertension after stress test, recent infarction, angina, pericarditis. Asthma stage 3, severe Chronic Obstructive Pulmonary Disease, bronchiectasis, pulmonary emphysema, pneumothorax, pleurisy, pulmonary infection, lobectomy ...) Epilepsy, deficit syndrome, iterative loss of knowledge, recent head trauma with loss of consciousness in difficulty, symptomatic cervical or lumbar disc herniation
  • Patient with medical treatment affecting the cardiovascular or respiratory system (for example: ventolin, betablocker ...)

研究组 & 干预措施

apnea performing

Experimental

The included subjects will make an apnea of two minutes or more, sitting on a chair with cold strips on the face, initially with the head in neutral position. Then, when they feel the end of their apnea, they will have to raise their left hand to signal it to the Doppler manipulator, who will then realize the apnea reference measurement.

As soon as this is done, the subjects will be asked to perform an extension of the neck, so as to look at the ceiling. A final measurement will then be made in apnea, the head always in extension. Subjects then resume their breathing in this same position. A final measurement will then be made.

干预措施: apnea performing (Other)

结局指标

主要结局

Effect of the voluntary neck extension in the occurrence of an increase in the pulsatility index of the right internal carotid artery in the amateur diver, realizing an apnea of two minutes or more

时间窗: 2 minutes or more: at the breaking point of apnea.

To demonstrate the potential implication of cervical extension in the decrease of cerebral blood flow in amateur diver apnea by measuring the variation in the pulsatility index of the right internal carotid artery (RICAPI), by the intra-individual comparison of the RICAPI in amateur diver in rupture of apnea with neck extension (NE) versus the RICAPI of amateur diver in rupture of apnea without NE.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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