Tongue Depressor-related Tongue Swelling

Tongue Depressor-related Tongue Swelling in Adenoidectomy Surgeries in Pediatric Patients

This study aimed to detect tongue swelling induced by the pressure exerted by tongue depressor; swelling detection was made through tongue surface area measurement using ultrasonography (USG) in pediatric patients who underwent adenoidectomy surgeries.

Study Overview

• Status: Completed
• Conditions: Adenoid Disease - Chronic; Complication; Children, Only; Side Effect; Adenoidal Hypertrophy
• Intervention / Treatment: Diagnostic test: Ultrasonography imaging

Detailed Description

The tongue is an ideal organ for ultrasonography (USG) evaluation. This study aimed to detect the occurrence of tongue swelling through USG examination and to educate clinicians about the association between subacute tongue swelling and tongue depressor in pediatric patients.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Turkey
  • Selcuklu
    • Konya, Selcuklu, Turkey, 42100
      • Selcuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients aged 16 years or younger who were to undergo adenoidectomy surgery were eligible for inclusion in this group. Informed consent was obtained from the parents of all the patients with a clinical diagnosis of chronic adenoiditis and adenoid hypertrophy (except tonsillectomy surgeries) and were to undergo adenoidectomy surgery.

Description

Inclusion Criteria:

• Patients aged 16 years or younger
• Undergo adenoidectomy surgery
• Patients informed consent obtained from the parents

Inclusion Criteria for control group:

• Patients aged 16 years or younger
• Patients who did not need adenoidectomy surgery and any head and neck procedures
• Patients who underwent endotracheal intubation under general anesthesia except adenoidectomy and head and neck surgery.

Exclusion Criteria:

• Patients aged older than 16 years
• Patients with a history of syndromal craniofacial abnormalities
• Patients with systemic disorders and other otolaryngologic problems

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study; Patients aged 16 years or younger who were to undergo adenoidectomy surgery were eligible for inclusion in this group. Tongue surface areas were measured twice by submental USG.The first measurements (TSA2) were done immediately after endotracheal intubation but before insertion and placement of the tongue depressor. The second measurements (TSA1) were done after adenoidectomy surgery and after removal of the tongue depressor but just before extubation. The difference between TSA2 and TSA1 (i.e., (TSA2-TSA1) was used to defined the occurrence of tongue swelling.	Diagnostic test: Ultrasonography imaging; This study aimed to measure the tongue surface areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue surface areas.
Control; This group included patients aged 16 years or younger who did not need adenoidectomy surgery and any head and neck procedures. Tongue surface areas of the patients were measured twice by submental USG as in the study group. TSA1s were done immediately after endotracheal intubation, and TSA2s were done at the end of the surgical procedure just before extubation. The difference between TSA2 and TSA1 (i.e., (TSA2-TSA1) was used to defined the occurrence of tongue edema.	Diagnostic test: Ultrasonography imaging; This study aimed to measure the tongue surface areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue surface areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from preoperative measurement to postoperative measurement in tongue surface area on the ultrasonography imaging.	This study aimed to evaluate the change from baseline in tongue surface area on the ultrasonography imaging due to the tongue depressor.	2018-2019 (6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of swelling formation in tongue by using ultrasonography imaging.	This study aimed to measure and detect the tongue swelling by using ultrasonography imaging due to the tongue depressor.	2018-2019 (6 months)

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Merih Onal, Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: children; ultrasonography; adenoid; tongue disease; enlarge tongue
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: 2018/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No