Tongue Depressor-related Tongue Swelling

Completed

• Conditions: Adenoidal Hypertrophy; Complication; Children, Only; Adenoid Disease - Chronic; Side Effect
• Interventions: Diagnostic Test: Ultrasonography imaging

• Registration Number: NCT04256590
• Lead Sponsor: Selcuk University

Brief Summary

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.

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 Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-04
• Last Update Submitted: 2020-02-04
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Ultrasonography imaging	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.
Study	Ultrasonography imaging	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Selcuk University; 🇹🇷 Konya, Selcuklu, Turkey