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

Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laryngeal Diseases; Ultrasound
• Intervention / Treatment: Diagnostic test: laryngeal ultrasound

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Thomas SAGARDOY, MD; Phone Number: 05.57.82.19.01; Email: thomas.sagardoy@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux, Hôpital Pellegrin, Service d'oto-rhino-laryngologie, de chirurgie cervico-faciale et d'ORL pédiatrique
    • Contact: Thomas SAGARDOY, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients treated in the pediatric ENT department at Bordeaux University Hospital, whether in consultation hospitalization.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducible ultrasound images	Define detailed and reproducible ultrasound images using consistent anatomical landmarks for diagnostic assessment of the larynx	At Baseline (D0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristics	We will evaluate the demographic characteristics that may affect the reproducibility of ultrasound images	At Baseline (D0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Thomas SAGARDOY, MD, CHU Bordeaux

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2024
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: pediatric population; ENT; otorhinolaryngology; transcutaneous laryngeal ultrasound
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases
• Other Study ID Numbers: CHUBX 2023/86

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No