Clinical Trials Directory

Trials / Completed

CompletedNCT06577051

Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy ± Adenoidectomy

Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy ± Adenoidectomy Without Tubal Dysfunction

Status
Completed
Phase
Study type
Observational
Enrollment
128 (actual)
Sponsor
Sumeyra DOLUOGLU · Academic / Other
Sex
All
Age
4 Years – 15 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTEustachian tube function test with 226 and 1000 Hz probesIn children undergoing tonsillectomy ± adenoidectomy without eustachian dysfunction, tympanometry with 226 Hz and 1000 Hz probes, ipsi and contralateral acoustic reflexes with 226 Hz probe, eustachian function test with 226 Hz probe (automatic Williams test) and play audiometry in young children and pure tone audiometry in older children are aimed to control tubal functions in preoperative period, postoperative day 1 and week 2.

Timeline

Start date
2024-08-20
Primary completion
2024-11-28
Completion
2024-11-30
First posted
2024-08-29
Last updated
2025-04-15

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06577051. Inclusion in this directory is not an endorsement.