Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577051
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy Adenoidectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy Adenoidectomy Without Tubal Dysfunction
Status:
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:
None
Brief Summary:
In children undergoing tonsillectomy adenoidectomy without eustachian dysfunction the objective is to control tubal functions with tympanometry utilising probes at 226 Hz and 1000 Hz as well as measuring the ipsilateral and contralateral acoustic reflexes with a 226 Hz probe An eustachian function test with a 226 Hz probe automatic Williams test and play audiometry are to be conducted on young children while pure tone audiometry is to be conducted on older children in the preoperative period on the first day after surgery and in the second week after surgery The primary objective is to ascertain whether the tubal functions which are hypothesised to be impaired on the first day return at the latest in the second week with all tests evaluating the eustachian tube both directly and indirectly The secondary objective is to determine whether this recovery occurs earlier with the 226 Hz probe or the 1000 Hz probe
Detailed Description:
None
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