Can Ventilatory Response at Rest Predict Ventilatory Efficacy and Exercise Tolerance in Patients With a Univentricular Congenital Heart Disease?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Pearson correlation - The measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest
研究概览
简要总结
The aim is to evaluate the correlation between the respiratory control to hypercapnia at rest and the VE/VCO2 slope measured during cardiopulmonary exercise testing.
The hypothesis is that patient with univentricular congenital heart disease have a increasing of respiratory drive like chronic heart failure. This increasing of respiratory drive could participate in the increasing of VE/VCO2 slope measured during cardiopulmonary exercise testing and in the genese of central apnea index during the sleep.
详细描述
The patients with univentricular congenital heart disease will perform :
- a cardiopulmonary exercise testing with measure VE/VCO2 slope,
- a measure of the respiratory drive to hypercapnia with occlusion pressure during the rebreathing with at rest (P0,1/PetCO2).
- A polysomnography with a scoring of central apnea index. Correlation will be evaluate between P 0,1/PetCO2 with VE/VCO2 slope and between P0,1/PetCO2 central apnea index.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functionally univentricular congenital heart disease
- •Age ≥ 8 years
- •Consent of the adult patient or the parents or legal guardians of the minor patient.
- •Beneficiary of the social security scheme
排除标准
- •Size <120 cm (minimum size for the stress test)
- •Medical contraindication to exercise test or presence of : myocardial infarction less than 3 months old, unstable angina, uncontrolled severe arrhythmias, symptomatic aortic stenosis, uncontrolled heart failure, pulmonary embolism, evolutionary phlebitis, pericarditis, myocarditis, progressive endocarditis, aortic dissection
- •Unstable patient with severe intellectual disability or complex pathology making polysomnography impossible
- •Pregnant woman
结局指标
主要结局
Pearson correlation - The measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest
时间窗: day 90 after inclusion visit (visit 2)
between the measure the respiratory drive to hypercapnia with P0.1 during the rebreathing technique at rest - between VE/VCO2 slope during a cardiopulmonary exercise
次要结局
- Pearson correlation(day 90 after inclusion visit (visit 2))