Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities. Pectus Excavatum Pectus-Carinatum. Single-center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- High frequency normalized index (HFnu)
研究概览
简要总结
The physiological assessment in non-operative treatment on chest wall deformities, are still unclear today. These functional benefits outweigh the aesthetic benefits associated with anatomical improvement. The functional benefits, ventilation, hemodynamic and neurologic, have never been evaluated.
Assessment of Effects on parasympathetic activity of the autonomic nervous system, global health criterion measured by noninvasive methods.
Anatomic evaluation, between the initial and final assessment by objective measures 1) of the chest wall by MRI, and 2) of the heart by echocardiography.
Noninvasive physiological assessment at rest and during exercise in respiratory function exploration flows and volumes, cardiac function by flow measurement, and overall metabolic function test effort (VO2max). Subjective assessment of functional gain between the initial and final balance sheet, based on EVA scales, valued by patients, parents and doctors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with pectus excavatum or pectus carinatum who does not require surgery
- •Patient with sufficient displacement of the chest wall during an initial test carried out during the first consultation :For pectus carinatum correction must be obtained with a pressure lower than 9 psi (pound per square inch). For pectus excavatum less than 250 mbar depression.
- •Signed informed consent
- •Subject (or parents) affiliated to the French National Health Insurance
排除标准
- •Skeletal disease, disturbing bone strength as osteogenesis imperfect and osteoporosis.
- •Uncontrolled coagulopathies.
- •Marfan syndrome, with mitral valve prolapse for pectus Excavatum.
- •Atrial fibrillation
- •Taking antiarrhythmic drug.
结局指标
主要结局
High frequency normalized index (HFnu)
时间窗: One month after the end of treatment
It is a reflect of the RR short term heart rate variability (HRV) in the frequency domain. It is measured with a ECG Holter monitor
次要结局
- Blood pressure - Baroreflex(One month after the end of treatment)
- Maximum heart rate(One month after the end of treatment)
- Lung residual volume(One month after the end of treatment)
- Maximum flow(One month after the end of treatment)
- Nuss Questionnaire(One month after the end of treatment)
- Aerobic maximum power(One month after the end of treatment)
- Severity index of the anatomical damage(One month after the end of treatment)
- Low frequency (LF and LFnu)(One month after the end of treatment)
- LF/HF ratio(One month after the end of treatment)
- Left ventricular ejection fraction(One month after the end of treatment)