Development of an Assessment Method for Obstructive Tonsillar Hypertrophy in Children by Ultrasonography

NCT ID: NCT04380272

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-02-01

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.

Conditions

Obstructive Tonsillar Hypertrophy

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Brodsky tonsil staging system

An oropharynx examination of all participants will be performed and tonsil size will be evaluated according to the Brodsky staging system. According to this staging system, tonsil sizes will be classified as stage I when the tonsils fill less than 25% of the transverse oropharyngeal space measured between the anterior tonsillar pillars; stage II when they fill between 25% and 50%, stage III when they fill between 50% and 75%, and stage IV when they fill more than 75%.

No interventions assigned to this group

The ultrasonographic data

The submental ultrasonography will be performed on all participants. Ultrasonographic examinations will be performed blinded to the physical examination results. All measurements will be performed by the same radiologist with experience in the field of ultrasonography. A GE LOGIQ E9 (GE Healthcare, Milwaukee, WI, USA) device will be used in the ultrasonography examination. The participants will be viewed using a 2-9 MHz linear probe from the submental region. The examination will be performed while the patient was lying in a supine position with a support placed under the neck.

The ROC analysis

Intervention Type: DIAGNOSTIC_TEST

The Brodsky clinical stage and ultrasonographic data of the participants will be matched, and the diagnostic value of the submental US in the classification of tonsil hypertrophy as non-obstructive and obstructive will be evaluated. A ROC analysis will be used to determine the optimal cut-off value.

Interventions

The ROC analysis

The Brodsky clinical stage and ultrasonographic data of the participants will be matched, and the diagnostic value of the submental US in the classification of tonsil hypertrophy as non-obstructive and obstructive will be evaluated. A ROC analysis will be used to determine the optimal cut-off value.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• The pediatric patients

Exclusion Criteria

• Adult patients
• Patients identified with active infections

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Erdem Mengi

Assistant Professor of Otorhinolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erdem Mengi

Role: PRINCIPAL_INVESTIGATOR

Pamukkale Üniversitesi Tıp Fakültesi

Locations

Erdem Mengi

Denizli, Pamukkale, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

60116787-020/81401

Identifier Type: -

Identifier Source: org_study_id