Tonsillar Retractor-induced Subacute Submassive Tongue Edema

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

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.

Study Overview

• Status: Completed
• Conditions: Children, Only; Side Effects; Tonsil Hypertrophy
• Intervention / Treatment: Diagnostic test: Ultrasonography imaging

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 Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Turkey
  • Selcuklu
    • Konya, Selcuklu, Turkey, 42100
      • Selcuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Diagnostic test: 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: children; ultrasonography; tonsil; diagnostic imaging
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: 2018/335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No