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临床试验/NCT06559293
NCT06559293尚未招募不适用

Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Reproducible ultrasound images

研究概览

简要总结

Nasofibroscopy is the gold standard for laryngeal pathology diagnosis. However, this examination is invasive and can be poorly tolerated in the pediatric population. Laryngeal ultrasound appears to be a better tolerated alternative. However, few data exist in the pediatric population in the literature. The aim of this study is to evaluate the feasibility of laryngeal ultrasound in a larger pediatric population of pathological and non-pathological subjects.

详细描述

According to current knowledge, the gold standard for diagnosing laryngeal pathologies is flexible fiberoptic laryngoscopy (FFL), as it allows visualisation of the motricity of the laryngeal structures and the appearance of the mucous membranes. However, this is an invasive examination, which can be poorly tolerated in the pediatric population. This poor tolerance can make it difficult to obtain an accurate diagnosis because of the child's movements. With the aim of improving patient comfort without compromising diagnostic performance, some studies describe laryngeal ultrasound (LUS) as an alternative to FFL. This imaging examination appears to be better tolerated than FFL because it is less invasive for the patient. However, there are few data available in the infant population. The main limitations of LUS are obtaining a satisfactory ultrasound window and inter-rater reproducibility. For these reasons, the aim of this study is to assess the feasibility of LUS in the pediatric population and to obtain reference frame enabling the different laryngeal structures to be visualised. We will include around one hundred patients treated in the pediatric ENT unit, with or without laryngeal pathology. An ultrasound record will be performed during the consultation in addition to the usual examination. The record will be analysed by a blinded assessor. A single consultation will be required and no follow-up is planned.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
0 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients treated in the pediatric ENT unit at Bordeaux University Hospital, aged between 0 and 15 years

排除标准

  • intubated patient,
  • haemodynamic
  • respiratory instability
  • opposition to participation expressed by parents or patient

结局指标

主要结局

Reproducible ultrasound images

时间窗: At Baseline (D0)

Define detailed and reproducible ultrasound images using consistent anatomical landmarks for diagnostic assessment of the larynx

次要结局

  • Demographic characteristics(At Baseline (D0))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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