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

Obstructive Tonsillar Hypertrophy Clinical Trial

Official title:

Development of an Assessment Method for Obstructive Tonsillar Hypertrophy in Children by Ultrasonography (Pamukkale Technique)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380272
• Other study ID #: 60116787-020/81401
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: May 2020
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• The pediatric patients

Exclusion Criteria:

• Adult patients

• Patients identified with active infections

Related Conditions & MeSH terms

• Hypertrophy
• Obstructive Tonsillar Hypertrophy

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Turkey	Erdem Mengi	Denizli	Pamukkale

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The evaluation of tonsil size according to the Brodsky tonsil staging system	The investigators will classify the Brodsky Stage I and II cases as non-obstructive tonsillar hypertrophy and the Brodsky stage III and IV as obstructive tonsillar hypertrophy.	20 minutes
Primary	The ultrasonographic intertonsillar distance, transverse length of the tongue base and the ratio of intertonsillar distance/transverse length of the tongue base	After the neck of the participant will be brought to extension, the ultrasound probe will be placed on the submental region, and both tonsils will be visualized in the midline in the transverse plane. The narrowest airway space will be marked between the two tonsils and the intertonsillar distance (ITD) will be measured. Subsequently, in the same region, the attachments of the palatoglossal muscles to the tongue base, as the projection of the anterior plicae, will be determined, and the widest transverse length of the tongue base (TLTB) at this level will be measured. The ratio of ITD to TLTB will be calculated for each participant.	20 minutes