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Tonsillar Retractor-induced Subacute Submassive Tongue Edema

NCT ID: NCT04204681

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-09-01

Brief Summary

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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

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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.

Conditions

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Side Effects Tonsil Hypertrophy Children, Only

Keywords

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ultrasonography children tonsil diagnostic imaging

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ultrasonography imaging

Intervention Type 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

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.

Ultrasonography imaging

Intervention Type 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.

Interventions

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Ultrasonography imaging

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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


* 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.

Exclusion Criteria

* Patients aged older than 16 years
* Patients with a history of syndromal craniofacial abnormalities
* Patients with systemic disorders and other otolaryngologic problems
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Ozkan Onal

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Selcuk University

Konya, Selcuklu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018/335

Identifier Type: -

Identifier Source: org_study_id