Tongue Depressor-related Tongue Swelling

NCT04256590 | Completed

• 1 other identifier: 2018/18
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Children, Only; Adenoidal Hypertrophy; Adenoid Disease - Chronic; Complication; Side Effect

Keywords

children; tongue disease; ultrasonography; enlarge tongue; adenoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Detection of swelling formation in tongue by using ultrasonography imaging.

  2018-2019 (6 months)

Study Arms (2)

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

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

Interventions

Ultrasonography imaging DIAGNOSTIC_TEST

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; Study

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tongue Diseases

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Merih Onal

  Selcuk University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: September 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

TU (1)