Clinical trial NCT04380272: Development of an Assessment Method for Obstructive Tonsillar Hypertrophy in Children by Ultrasonography
Official title: Development of an Assessment Method for Obstructive Tonsillar Hypertrophy in Children by Ultrasonography (Pamukkale Technique)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Tonsillar Hypertrophy
Keywords: tonsil
tonsillar hypertrophy
ultrasonography
children
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 102
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The pediatric patients who presented to the otorhinolaryngology outpatient clinic with complaints of recurrent tonsillitis, snoring, and/or witnessed apnea between January 2019 and December 2019.

Brief summary: Chronic tonsillar hypertrophy is one of the most common causes of upper airway obstruction in children. Currently, several clinical staging systems are used to evaluate airway obstruction due to tonsillar hypertrophy. However, as these staging systems are based on a physical examination, it is not always possible to accurately evaluate the tonsil size, especially in children, and so objective and reliable methods are required in this field. In this study, the investigators aimed to develop a new method for the objective evaluation of airway obstruction due to tonsillar hypertrophy using submental ultrasonography (US) in children.

Detailed description: Tonsillectomy is one of the most frequently performed operations in childhood, and one of the most important indications of this surgery is chronic tonsillar hypertrophy. Chronic tonsillar hypertrophy accounts for 80% of cases with obstructive sleep apnea syndrome (OSAS) in childhood, and growth and development delay, low academic performance, facial developmental abnormalities, and cardiopulmonary diseases may emerge as a result. For this reason, an accurate evaluation of tonsil size is crucial both during clinical follow-up and in tonsillectomy decisions.

Currently, several clinical staging systems are used to evaluate tonsil size in children, with the "Brodsky" and "Friedman" scales being the most commonly used systems. These staging systems make use of a physical examination, with tonsil hypertrophies generally classified into 4 stages based on the extension of the tonsil from the anterior plica to the midline. Stages 3 and 4 tonsil hypertrophy are generally accepted as obstructive, and a tonsillectomy decision is made when clinical complaints support this. For such an evaluation of tonsil grade, the child should be cooperative, should easily open his/her mouth, and should not gag. In the event of the patient's non-compliance, the size of the tongue and tongue base, the hyperactive gag reflex, and trismus may challenge this evaluation. The gag reflex during the examination causes the tonsils to move towards the midline, making the tonsils seem bigger than the real size. An obstruction at the hypopharyngeal level due to hypertrophic tonsils may be missed due to poor visualization of the inferior pole of the tonsil in patients with a large tongue. For these reasons, a correct clinical evaluation of the tonsil size may not always be possible through a physical examination. Thus objective and reliable methods are required for the classification of tonsillar hypertrophy.

There have been no studies to date investigating the use of ultrasonography (US) in the evaluation of airway obstruction due to tonsillar hypertrophy, despite the advantages of high patient compliance, low cost, and no radiation exposure. The present study suggests a new method for the evaluation of airway obstruction due to tonsillar hypertrophy using the submental US in children.

Eligibility criteria: Inclusion Criteria:

* The pediatric patients

Exclusion Criteria:

* Adult patients
* Patients identified with active infections

Primary outcomes:
measure: The evaluation of tonsil size according to the Brodsky tonsil staging system
timeFrame: 20 minutes
measure: The ultrasonographic intertonsillar distance, transverse length of the tongue base and the ratio of intertonsillar distance/transverse length of the tongue base
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Erdem Mengi
state: Pamukkale
Study officials:
affiliation: Pamukkale Üniversitesi Tıp Fakültesi
name: Erdem Mengi
role: PRINCIPAL_INVESTIGATOR
References: