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

NCT06559293 | Not Yet Recruiting

• 1 other identifier: CHUBX 2023/86
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Diseases; Ultrasound

Keywords

transcutaneous laryngeal ultrasound; pediatric population; otorhinolaryngology; ENT

Outcome Measures

Primary Outcomes (1)

• Reproducible ultrasound images

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

  At Baseline (D0)

Secondary Outcomes (1)

• Demographic characteristics

  At Baseline (D0)

Interventions

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.

Eligibility Criteria

• Age: 0 Years - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

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

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Thomas SAGARDOY, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas SAGARDOY, MD

CONTACT

05.57.82.19.01; thomas.sagardoy@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: September 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

FR (1)