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

Completed

• Conditions: Tonsillar Hypertrophy; Eustachian Tube Dysfunction; Tympanic Membrane Disorder; Eustachian Tube Dysfunction of Both Ears
• Interventions: Diagnostic Test: Eustachian tube function test with 226 and 1000 Hz probes

• Registration Number: NCT06577051
• Lead Sponsor: Sumeyra DOLUOGLU

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

Not available

Study Timeline

• Study Start: 2024-08-20
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-29
• Primary Completion: 2024-11-28
• Study Completion: 2024-11-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children undergoing tonsillectomy ± adenoidectomy without tubal dysfunction	Eustachian tube function test with 226 and 1000 Hz probes	* 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

Primary Outcome Measures

Name	Time	Method
Evaluation the functionality of the eustachian tube with odiometric tests	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 Outcome Measures

Name	Time	Method
Evaluation the functionality of the eustachian tube with tympanometry the 226 Hz and 1000 Hz probes	21 days	It was investigated which of the 226 Hz and 1000 Hz probes used in these tests detected earlier recovery findings.

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Turkey