Tonsillar Retractor-induced Subacute Submassive Tongue Edema

Study Overview
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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.

Official Title
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Tonsillar Retractor-induced Subacute Submassive Tongue Edema: A New Cause of Late Respiratory Complications in Pediatric Patients Undergoing Tonsillectomy and a Condition Detected by Ultrasonography

Conditions
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Side Effects, Tonsil Hypertrophy, Children, Only

Intervention / Treatment
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* Diagnostic Test: Ultrasonography imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for study group: Patients aged 16 years or younger Undergo tonsillectomy surgery Patients informed consent obtained from the parents Exclusion Criteria for study group: Patients aged older than 16 years Patients with a history of syndromal craniofacial abnormalities Patients with systemic disorders and other otolaryngologic problems Inclusion Criteria for control group: 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study<br>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<br>* 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.<br>|
| Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasonography, children, tonsil, diagnostic imaging