Clinical trial NCT06559293: Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population - ECHO LARYNX
Official title: Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Laryngeal Diseases
Ultrasound
Keywords: transcutaneous laryngeal ultrasound
pediatric population
otorhinolaryngology
ENT
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 15
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in the pediatric ENT department at Bordeaux University Hospital, whether in consultation hospitalization.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reproducible ultrasound images
timeFrame: At Baseline (D0)
Secondary outcomes:
measure: Demographic characteristics
timeFrame: At Baseline (D0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux, Hôpital Pellegrin, Service d'oto-rhino-laryngologie, de chirurgie cervico-faciale et d'ORL pédiatrique
Study officials:
affiliation: University Hospital, Bordeaux
name: Thomas SAGARDOY, MD
role: PRINCIPAL_INVESTIGATOR
References: