Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Severity of dynamic narrowing on Flexible Bronchoscopy
研究概览
简要总结
The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom flexible bronchoscopy has been performed. The primary aims are to evaluate the diagnostic accuracy, image quality, and radiation exposure of DA-CT as a potential noninvasive alternative to the gold standard of flexible bronchoscopy in the diagnosis of tracheomalacia. The results from this pilot study will help to estimate sample size for a larger-scale study with more precise estimates of DA-CT diagnostic potential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 0-18 years old, with
- •Clinically indicated flexible bronchoscopy has been performed
排除标准
- •Pregnancy or breastfeeding
- •Unable to undergo CT scanning without sedation
- •Patients with tracheostomy
结局指标
主要结局
Severity of dynamic narrowing on Flexible Bronchoscopy
时间窗: Through study completion, an average of 1 year
Video recordings and images will be deidentified and reviewed by pediatric pulmonologists and scores averaged. Severity of dynamic narrowing will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: \>90%.
Severity of Excessive dynamic airway collapse (EDAC) on DA-CT
时间窗: Through study completion, an average of 1 year
Severity of EDAC will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: \>90%. This outcome will be measured using the following equation: EDAC = CSA at airway segment in expiration/CSA at same location in inspiration
Severity of Maximal Airway Change (MAC) on DA-CT
时间窗: Through study completion, an average of 1 year
Severity of MAC will be classified as follows: mild: 33%-49%, moderate: 50%-66%, severe: \>67%. This outcome will be measured using the following equation: MAC = tracheal cross-sectional (CSA) at narrowed segment in inspiration/CSA of trachea at thoracic inlet in inspiration
次要结局
- Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale(Through study completion, an average of 1 year)
- Qualitative Analysis of DA-CT image noise based on 5-point Likert scale(Through study completion, an average of 1 year)
- Qualitative Analysis of DA-CT delineation of small airways based on 5-point Likert scale(Through study completion, an average of 1 year)
- Radiation exposure of DA-CT scanners(Through study completion, an average of 1 year)
- Qualitative Analysis of DA-CT delineation of large airways based on 5-point Likert scale(Through study completion, an average of 1 year)
- Contrast-to-noise-ratio (CNR) of DA-CT scanners(Through study completion, an average of 1 year)
- Qualitative Analysis of DA-CT noise texture based on 5-point Likert scale(Through study completion, an average of 1 year)