Tonsillar Retractor-induced Subacute Submassive Tongue Edema

Children, Only Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04204681
• Other study ID #: 2018/335
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: December 2019
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children, Only
• Hypertrophy
• Side Effects
• Tonsil Hypertrophy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya	Selcuklu

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)