Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation: A Physiological Study on Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Collapsibility score for the IVC diameter
研究概览
简要总结
The main objective of this study is to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 50% collapsibility of the inferior vena cava.
详细描述
Secondary objectives of this study are:
- to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 40% collapsibility of the inferior vena cava (IVC).
- to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 100% collapsibility of the IVC.
- to determine the location of the cutting plane for the TM analysis of collapsibility of the IVC.
- to evaluate the hemodynamic conditions of normal healthy volunteers.
- to detect any abnormality of cardiac function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The volunteer must have given his/her informed and signed consent
- •The volunteer must be insured or beneficiary of a health insurance plan
排除标准
- •The volunteer is participating in another study
- •The volunteer is in an exclusion period determined by a previous study
- •The volunteer is under judicial protection, under tutorship or curatorship
- •The volunteer refuses to sign the consent
- •It is impossible to correctly inform the volunteer
- •The patient is pregnant, parturient, or breastfeeding
- •The volunteer has known heart disease like heart failure, cardiac arrhythmia
- •The volunteer takes cardiotropics
- •The volunteer has known lung disease: obstructive or restrictive respiratory failure
- •The volunteer has clinical signs of COPD (coughing with morning sputum in a smoking subject)
- •Any emergency situation
结局指标
主要结局
Collapsibility score for the IVC diameter
时间窗: Baseline (Day 0; cross-sectional study)
percentage = ((max-min)/average)\*100% Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is \>= 50%; and (3) a measure of the diaphragmatic excursion.
Collapsibility score for the IVC diameter >= 50% (presence/absence)
时间窗: Baseline (Day 0; cross-sectional study)
percentage = ((max-min)/average)\*100% Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is \>= 50%; and (3) a measure of the diaphragmatic excursion.
Diaphragmatic excursion
时间窗: Baseline (Day 0; cross-sectional study)
Maximum distance between the position of the diaphragmatic dome during inspiration versus expiration (cm) Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is \>= 50%; and (3) a measure of the diaphragmatic excursion.
次要结局
- Collapsibility score for the IVC diameter >= 40% (presence/absence)(Baseline (Day 0; cross sectional study))
- Collapsibility score for the IVC diameter >= 60% (presence/absence)(Baseline (Day 0; cross sectional study))
- Mitral Doppler Wave E speed(Baseline (Day 0; cross sectional study))
- Collapsibility score for the IVC diameter >= 40% (presence/absence)(Baseline (Day 0; cross sectional study))
- Collapsibility score for the IVC diameter >= 60% (presence/absence)(Baseline (Day 0; cross sectional study))
- Mitral Doppler Wave E speed(Baseline (Day 0; cross sectional study))
- Mitral Doppler Wave A speed(Baseline (Day 0; cross sectional study))
- Tissue Doppler Wave E' speed(Baseline (Day 0; cross sectional study))
- Simpson: FEVG(Baseline (Day 0; cross sectional study))