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

NCT04380272 | Completed

• 1 other identifier: 60116787-020/81401
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Tonsillar Hypertrophy

Keywords

tonsil; tonsillar hypertrophy; ultrasonography; children

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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%.

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.

Diagnostic Test: The ROC analysis

Interventions

The ROC analysis 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.

The ultrasonographic data

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• The pediatric patients

You may not qualify if:

• Adult patients
• Patients identified with active infections

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Erdem Mengi

Denizli, Pamukkale, 20070, Turkey (Türkiye)

Location

Study Officials

• Erdem Mengi

  Pamukkale Üniversitesi Tıp Fakültesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Otorhinolaryngology

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 8, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: February 1, 2020
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)