Ultrasound Functional Analysis of the Diaphragm and Upper Digestive Tract in Patients with Congenital Diaphragmatic Hernia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with or without a prosthesis and a group of children without any diaphragmatic pathology.
研究概览
简要总结
This diaphragmatic elastography study is a preliminary pilot study to have first values of diaphragmatic stiffness in patients with a history of diaphragmatic hernia and to estimate the difference in stiffness compared to a group of patients without a history of hernia.
The hypothesis is to be able to correlate the values found with the patients' symptomatology and thus to better monitor patients by a simple, accessible, painless and reproducible diagnostic tool, to better understand their evolution and even to be able to anticipate possible difficulties (reflux, respiratory disorders, scoliosis, etc.).
Ultrasound elastography is a recent and clinically recognized method that uses an ultrasound approach to determine tissue stiffness in a non-invasive way.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group HDC:
- •Patient followed at the CCMR (centres de compétence maladies rares) HDC of the Strasbourg University Hospital
- •Aged between 3 and 17 years old inclusive
- •Indifferent Sex
- •Subject affiliated to a social protection health insurance scheme or beneficiary of such a scheme
- •Subject able to understand the objectives and risks of the research and to provide dated and signed informed consent
- •Subject who has been informed of the results of the preliminary medical examination
- •Control group:
- •Subject followed in pediatric surgery
- •Aged between 3 and 17 years old inclusive
- •Indifferent Sex
- •Subject affiliated to a social protection health insurance scheme or beneficiary of such a scheme
- •Subject able to understand the objectives and risks of the research and to provide dated and signed informed consent
- •Subject who has been informed of the results of the preliminary medical examination
排除标准
- •Group HDC:
- •Language barrier
- •Diaphragmatic surgery within the last 3 months
- •Patient with a viral picture in progress at the time of examination (assessment by the investigator)
- •Patient treated with muscle relaxant
- •Inability to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
- •Subject under safeguard of justice
- •Subject under guardianship or curatorship
- •Pregnant or breastfeeding woman
- •Control group:
- •Patient without thoracic pathology
- •Language barrier
- •Diaphragmatic pathology
- •Any myopathy
- •History of surgery of the upper digestive tract (esophagus and/or gastric and/or duodenal)
- •Patient on muscle relaxant
- •Patient with a viral picture in progress at the time of examination (assessment by the investigator)
- •Patient treated with muscle relaxant
- •Inability to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
- •Subject under safeguard of justice
- •Subject under guardianship or curatorship
- •Pregnant or breastfeeding woman
结局指标
主要结局
To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with or without a prosthesis and a group of children without any diaphragmatic pathology.
时间窗: Baseline
Diaphragmatic rigidity in ultrasound elastographic analysis: measurement of diaphragm stiffness in shear wave elastography, in apnea (measurement in kPa).
次要结局
- To evaluate the correlation between age and the different parameters measured by ultrasound (on the total population and then within the 3 groups: no hernia, hernia with plaque, hernia without plaque)(Baseline)
- To estimate the association between patient stiffness and symptomatology in HDC subjects.(Baseline)
- To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with a prosthesis and a group of children with a diaphragmatic hernia without a prosthesis.(Baseline)