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

Not yet recruiting

• Conditions: Laryngeal Diseases; Ultrasound

• Registration Number: NCT06559293
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Study Start: 2024-09-15
• Primary Completion: 2024-09-15
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reproducible ultrasound images	At Baseline (D0)	Define detailed and reproducible ultrasound images using consistent anatomical landmarks for diagnostic assessment of the larynx

Secondary Outcome Measures

Name	Time	Method
Demographic characteristics	At Baseline (D0)	We will evaluate the demographic characteristics that may affect the reproducibility of ultrasound images

Trial Locations

Locations (1)

CHU de Bordeaux, Hôpital Pellegrin, Service d'oto-rhino-laryngologie, de chirurgie cervico-faciale et d'ORL pédiatrique; 🇫🇷 Bordeaux, France