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

NCT06577051 | Completed

• 1 other identifier: SumeyraDoluoglu
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Eustachian tube; Tubal dysfunction; Tympanometry; High-frequency tympanometry; Eustachian tube dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  21 days

Study Arms (1)

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

Interventions

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.

Children undergoing tonsillectomy ± adenoidectomy without tubal dysfunction

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Sumeyra DOLUOGLU: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (1)

• Doluoglu S, Gazeloglu AZ, Ulger N, Camalan BV, Dagli M. Evaluation of Eustachian tube function with dynamic and static tests in children undergoing adenotonsillectomy: A prospective clinical study. Int J Pediatr Otorhinolaryngol. 2025 Sep;196:112488. doi: 10.1016/j.ijporl.2025.112488. Epub 2025 Jul 14.

  PMID: 40663994 DERIVED

Study Officials

• Sumeyra Doluoglu, MD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 29, 2024
• Study Start: August 20, 2024
• Primary Completion: November 28, 2024
• Study Completion: November 30, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

TU (1)