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

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.

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Key information

Conditions

Tonsillar Hypertrophy Eustachian Tube Dysfunction Eustachian Tube Dysfunction of Both Ears Tympanic Membrane Disorder

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

4-15 years old child patient
No preoperative tubal dysfunction detected in the patient
Willingness to participate in the study by the patient and his/her parents
The patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
No bleeding disorder or disease

Exclusion criteria

<3 years old, >15 years old paediatric patient
Tubal dysfunction detected preoperatively
Not wanting to participate in the study at any stage of the study
The patient has craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
Having a bleeding disorder or disease

Treatment and study plan

Eustachian tube function test with 226 and 1000 Hz probes

Diagnostic Test

In 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.

Primary outcomes

Evaluation the functionality of the eustachian tube with odiometric tests

Time frame: 14 days

Evaluation the functionality of the eustachian tube, which was presumed to be compromised on the initial post-adenotonsillectomy day, and ascertainment whether it had recuperated by the second week. Tympanometry with 226 and 1000 Hz probes, eustachian function test with 226 Hz probe, ipsi and contralateral acoustic reflexes with 226 Hz probe and pure tone-play audiometry were performed in all patients one day before the operation. All tests were repeated on postoperative day 1 before the patient was discharged. All tests were repeated at the 2nd postoperative week.

Secondary outcomes

Evaluation the functionality of the eustachian tube with tympanometry the 226 Hz and 1000 Hz probes

Time frame: 21 days

It was investigated which of the 226 Hz and 1000 Hz probes used in these tests detected earlier recovery findings.

Sponsors and collaborators

Lead sponsor

Sumeyra DOLUOGLU

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Aug 29, 2024
Registry last updated: Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed