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

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.

Study Overview

• Status: Completed
• Conditions: Eustachian Tube Dysfunction; Tonsillar Hypertrophy; Eustachian Tube Dysfunction of Both Ears; Tympanic Membrane Disorder
• Intervention / Treatment: Diagnostic test: Eustachian tube function test with 226 and 1000 Hz probes

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged 4-15 years who underwent tonsillectomy ± adenoidectomy for chronic tonsillitis or sleep breathing disorder without eustachian tube dysfunction were included in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Children undergoing tonsillectomy ± adenoidectomy without tubal dysfunction; 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

Diagnostic test: Eustachian tube function test with 226 and 1000 Hz probes; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation the functionality of the eustachian tube with odiometric tests	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.	14 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sumeyra DOLUOGLU
• Investigators: Principal Investigator: Sumeyra Doluoglu, MD, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): November 28, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Eustachian tube; Eustachian tube dysfunction; Tympanometry; Tubal dysfunction; High-frequency tympanometry
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: SumeyraDoluoglu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No