The Associations Between EIT and Clinical Measures During Standard of Care Procedures in Patients With Respiratory Disease: A Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung.
研究概览
简要总结
The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT) imaging system for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. The EIT does not use radiation, and is read through electrodes.
详细描述
The purpose of this study is to evaluate EIT for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls.
Researchers will use EIT to determine changes in regional ventilation with pulmonary interventions including airway clearance and invasive and noninvasive ventilation in a pediatric respiratory disease population.
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
- 14 Days 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 weeks old - 40 years old
- •Premature infants with current age >2 weeks with a confirmed diagnosis of BPD based on NIH criteria
- •Or Chronic respiratory disease due to underlying neuromuscular disease
- •Or confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of DMD or other diagnoses associated with mild cardiomyopathy.
- •have had a VQ scan
- •will be undergoing cardiac catherization for for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis
- •Or healthy controls
排除标准
- •<2 weeks of age
- •Congenital diaphragmatic hernia
- •Severe congenital heart disease
- •Significant genetic abnoralities
- •Anything that interferes with lead placement on the chest wall
- •Unwilling/refusal to sign consent
- •Pregnant or lactating
- •Pacemaker of other surgical implant and spinal implant (causes noise in the data)
- •Moderate to severe cardiomyopathy
- •Patients with temporary cognitive disability due to illness
结局指标
主要结局
EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung.
时间窗: 24 months
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 pulsatile perfusion imaging at the end of systole(5 minutes)
- Power waveform (computed as the inner product of measured voltages and applied currents)(24 months)
- Regional conductivity changes due to ventilation(24 months)
- Waveform for a mesh element(24 months)
- Regional conductivity changes due to perfusion(24 months)