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NCT Number: NCT06559293

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

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.

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Key information

Age range

0 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bordeaux, 33076, France

Location contact

Thomas SAGARDOY, MD

CONTACT

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laryngeal ultrasound

Diagnostic Test

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.

Primary outcomes

  1. Reproducible ultrasound images

    Time frame: At Baseline (D0)

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

Secondary outcomes

  1. Demographic characteristics

    Time frame: At Baseline (D0)

    We will evaluate the demographic characteristics that may affect the reproducibility of ultrasound images

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas SAGARDOY, MD

CONTACT

[email protected]

05.57.82.19.01

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population

Acronym: ECHO-LARYNX

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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