Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 5
- 主要终点
- Cardiac output difference before and after intervention,during an exercise stress test
研究概览
简要总结
this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the cardiac output difference before and after intervention, measured by transthoracic impedancemetry, during an exercise stress test
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
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients seeking treatment of a pectus excavatum
- •Haller index > 3.2
- •Desire for treatment
- •age between 15 and 40 years old
排除标准
- •Cognitive impairment
- •Pregnancy
- •Contraindication to exercise stress test or general anesthesia
- •Coagulation disorders
研究组 & 干预措施
Surgical treatment group
patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).
intervention: surgical correction (Ravitch or Nuss type intervention).
干预措施: surgical treatment (Procedure)
Orthopedic treatment group
patients who chose an orthopedic treatment by vacuum bell. intervention : orthopedic treatment by vacuum bell.
干预措施: orthopedic treatment (Procedure)
结局指标
主要结局
Cardiac output difference before and after intervention,during an exercise stress test
时间窗: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Cardiac output measured by transthoracic impedancemetry, during an exercise stress test
次要结局
- Rest lung function tests(4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3))
- Quality of life(4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3))
- Evaluation of postoperative neuropathic pain(4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3))
- Mean energy expenditure(4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3))
- Exercise functional capacity(4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3))
- Exercise cardiac output(4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3))