Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559293
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population - ECHO LARYNX
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECHO-LARYNX
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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None