Tonsillar Retractor-induced Subacute Submassive Tongue Edema

Completed

• Conditions: Tonsil Hypertrophy; Children, Only; Side Effects
• Interventions: Diagnostic Test: Ultrasonography imaging

• Registration Number: NCT04204681
• Lead Sponsor: Selcuk University

Brief Summary

This study aimed to detect tongue edema induced by the pressure exerted by tonsillar retractor; edema detection was made through tongue area measurement using ultrasonography (USG) in pediatric patients who underwent tonsillectomy surgeries.

Detailed Description

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

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-09-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Last Update Submitted: 2019-12-18
• Study First Posted: 2019-12-19
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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 tonsillectomy surgery and any head and neck procedures. Tongue areas of the patients were measured twice by submental USG as in the study group. TA1s were done immediately after endotracheal intubation, and TA2s were done at the end of the surgical procedure just before extubation. The difference between TA2 and TA1 (i.e., (TA2-TA1) was used to defined the occurrence of tongue edema.
Study	Ultrasonography imaging	Patients aged 16 years or younger who were to undergo tonsillectomy surgery were eligible for inclusion in this group. Tongue areas were measured twice by submental USG.The first measurements (TA2) were done immediately after endotracheal intubation but before insertion and placement of the tonsillar retractor. The second measurements (TA1) were done after tonsillectomy surgery and after removal of the tonsillar retractor but just before extubation. The difference between TA2 and TA1 (i.e., (TA2-TA1) was used to defined the occurrence of tongue edema.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Selcuk University; 🇹🇷 Konya, Selcuklu, Turkey