Clinical trial NCT06577051: Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy ± Adenoidectomy
Official title: Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy ± Adenoidectomy Without Tubal Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 128
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation the functionality of the eustachian tube with odiometric tests
timeFrame: 14 days
Secondary outcomes:
measure: Evaluation the functionality of the eustachian tube with tympanometry the 226 Hz and 1000 Hz probes
timeFrame: 21 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Sumeyra Doluoglu, MD
role: PRINCIPAL_INVESTIGATOR
References: