The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- The yield of US in diagnosing laryngomalacia in comparison to FLB.
研究概览
简要总结
The hypothesis of the study is that laryngeal US can accurately and reliably diagnose laryngomalacia in infants with congenital stridor.
Stridor is a respiratory noise caused by partial obstruction of the large airways at the level of the pharynx, larynx and/or trachea. The most prevalent congenital cause of stridor is laryngomalacia. Flexible laryngobronchoscopy (FLB) under sedation is regarded as the gold standard. However, FLB under sedation has some drawbacks as it requires venous access, use of sedative agents, may cause discomfort for the patient and is costly.
Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique. It allows for dynamic assessment of moving structures in an awake patient and the results can be easily displayed and recorded.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants referred for FLB and bronchoscopy due to congenital stridor at the Department of Pediatric Pulmonology, Critical Care and Sleep Medicine at the Tel Aviv Sourasky Medical Centre
排除标准
- •Prior knowledge of the cause for stridor
- •History of foreign body aspiration
研究组 & 干预措施
laryngeal ultrasound stridor
During the study period, infants referred for FLB and bronchoscopy due to congenital stridor at the Department of Pediatric Pulmonology, Critical Care and Sleep Medicine at the Tel Aviv Sourasky Medical Centre will undergo an awake US of the larynx prior to performing the Flexible bronchoscopy.
干预措施: laryngeal ultrasound (Other)
laryngeal ultrasound -control
Infants matched for age referred for flexible bronchoscopy for reasons other than stridor will undergo an awake US of the larynx.
干预措施: laryngeal ultrasound (Other)
结局指标
主要结局
The yield of US in diagnosing laryngomalacia in comparison to FLB.
时间窗: December 2013- January 2015 (13 months)
次要结局
- The yield of US in diagnosing other causes of congenital stridor compared to FLB.(December 2013- January 2015 (13 months))