New Strategies for Pulmonary Assessment in Spinal and Chest Wall Deformity
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Analyze volume of lungs at end-inspiration and end-expiration
研究概览
简要总结
Thoracic insufficiency syndrome (TIS) is a complex condition that involves chest wall deformities that can affect normal breathing and lung growth. In most cases, children with TIS are also born with spine disorders such as scoliosis. The inability of the thorax to support normal respiration or lung growth can cause respiratory distress and even mortality. Investigators aim to validate MRI imaging sequences to use as an assessment tool for pulmonary 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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 6 to 18 years old diagnosed with thoracic insufficiency syndrome who are undergoing surgery
排除标准
- •patients not diagnosed with thoracic insufficiency syndrome
研究组 & 干预措施
Thoracic Insufficiency Group
Thoracic insufficiency syndrome patients undergoing surgery
干预措施: Xenon-129 (Device)
结局指标
主要结局
Analyze volume of lungs at end-inspiration and end-expiration
时间窗: up to 2 years
Investigators will analyze lung volume at end-inspiration and end-expiration will be assessed by performing a thoracic dynamic magnetic resonance imaging scan; measured in total volume units (mL)
Xenon-129 MRI Ventilation Maps
时间窗: up to 2 years
Xenon-129 MRI will be completed to reveal unventilated regions of the lungs where the gas cannot reach after being inhaled due to restrictions of the airways.
次要结局
- total lung capacity(up to 2 years)
- oxygen partial pressure (PAO2) maps(up to 2 years)
- Forced vital capacity (FVC)(up to 2 years)
- Xenon-129 MRI apparent diffusion coefficient (ADC) maps(up to 2 years)
- Forced expiratory volume (FEV1)(up to 2 years)
- functional residual capacity (FRC)(up to 2 years)
研究者
Patrick Cahill, MD
Attending physician
Children's Hospital of Philadelphia