Tonsillar Retractor-induced Subacute Submassive Tongue Edema

NCT04204681 | Completed

• 1 other identifier: 2018/335
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Side Effects; Tonsil Hypertrophy; Children, Only

Keywords

ultrasonography; children; tonsil; diagnostic imaging

Outcome Measures

Primary Outcomes (1)

• Change from preoperative measurement to postoperative measurement in tongue area on the ultrasonography imaging.

  This study aimed to evaluate the change from baseline in tongue area on the ultrasonography imaging due to the tonsillar retractor.

  2018-2019 (6 months)

Secondary Outcomes (1)

• Detection of edema 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 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.

Diagnostic Test: Ultrasonography imaging

Control

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.

Diagnostic Test: Ultrasonography imaging

Interventions

Ultrasonography imaging DIAGNOSTIC_TEST

This study aimed to measure the tongue areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue 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 tonsillectomy 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 tonsillitis and tonsillar hypertrophy (except adenoidectomy surgeries) and were to undergo tonsillectomy surgery.

You may qualify if:

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

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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

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

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: November 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)