Characterizing the Evolution of Neonatal Lung Disease Throughout Infancy and Childhood Using Electrical Impedance Tomography: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- EIT Imaging Maps that provide information about regional ventilation and perfusion of the lung
研究概览
简要总结
This study plans to learn more about ways to look at participant's lungs using new machines called Electrical Impedance Tomography (EIT). The EIT does not use harmful radiation like CT or x-ray. It is read through electrodes like using EKG reading heartbeats.
The investigators want to compare the results of patients who have chronic respiratory disease to patients without chronic respiratory disease to learn more about lung structure and composition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Weeks 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 weeks to 25 years of age
- •evidence of cardiopulmonary disease including, but not limited to:
- •Post-prematurity respiratory disease
- •Congenital diaphragmatic hernia
- •Pulmonary Hypertension
- •Congenital heart disease
- •Respiratory failure
- •Neuromuscular Disease
- •Developmental or congenital lung disease
- •OR matched healthy controls (born at term gestation (>36 weeks gestational age) with no cardiopulmonary disease)
排除标准
- •<2 weeks of age
- •Anything that interferes with lead placement on the chest wall (such as, dermatologic conditions, multiple chest tubes, anatomic abnormality, or large dressings that cannot be moved)
- •No informed consent
- •Pregnant or lactating
- •Pacemaker or other metal intrathoracic surgical implant (causes noise in the data)
研究组 & 干预措施
Cardiopulmonary disease
Have evidence of cardiopulmonary disease including, but not limited to:
- Post-prematurity respiratory disease
- Congenital diaphragmatic hernia
- Pulmonary hypertension
- Congenital heart disease
- Respiratory failure
- Neuromuscular disease
- Developmental or congenital lung disease
May be imaged with two machines
干预措施: Electrical impedance tomography (EIT) (Device)
Control
matched healthy controls with no cardiopulmonary disease
干预措施: Electrical impedance tomography (EIT) (Device)
结局指标
主要结局
EIT Imaging Maps that provide information about regional ventilation and perfusion of the lung
时间窗: 4 hours
These images will be analyzed both visually for qualitative abnormalities and through quantitative pixel analysis that can provide information regarding lung volume, blood volume, and changes in either based on respiratory cycle, cardiac cycle, or intervention. Areas of low ventilation (atelectasis and consolidation) will be identified.
次要结局
- Regional Conductivity Due to Ventilation(4 hours)
- Regional Conductivity Due to Perfusion(4 hours)
- Comparison of Ventilation and Perfusion Ratio(4 hours)