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

U

University Hospital of Bordeaux

Status

Not yet enrolling

Conditions

Laryngeal Diseases
Ultrasound

Treatments

Diagnostic Test: laryngeal ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT06559293
CHUBX 2023/86

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

Under 15 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Thomas SAGARDOY, MD

Data sourced from clinicaltrials.gov

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