Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population - ECHO LARYNX

Официальное название

Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест laryngeal ultrasound
  laryngeal ultrasound with linear probe will be positioned on the patient's neck. A list of anatomical sites to be visualised will be determined beforehand. Once all the pre-determined structures have been visualised, in an axial and sagittal plane, we will note the position of the ultrasound probe and its orientation. This will enable us to determine the ideal position of the ultrasound probe for obtaining all the elements of interest on a section that will be called the reference section.

Первичные конечные точки

• Reproducible ultrasound images [Срок оценки: At Baseline (D0)]

Вторичные конечные точки (1)

• Demographic characteristics [Срок оценки: At Baseline (D0)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 1 центр

• CHU de Bordeaux, Hôpital Pellegrin, Service d'oto-rhino-laryngologie, de chirurgie cervico — Bordeaux

Идентификаторы

NCT: NCT06559293 · CHUBX 2023/86

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗