Tonsillar Retractor-induced Subacute Submassive Tongue Edema

Sponsor
Selcuk University (Other)
Overall Status
Completed
CT.gov ID
NCT04204681
Collaborator
(none)
61
1
10
6.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
61 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Actual Study Start Date :
Nov 1, 2018
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Change from preoperative measurement to postoperative measurement in tongue area on the ultrasonography imaging. [2018-2019 (6 months)]

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

Secondary Outcome Measures

  1. Detection of edema formation in tongue by using ultrasonography imaging. [2018-2019 (6 months)]

    This study aimed to measure and detect the tongue edema by using ultrasonography imaging due to the tonsillar retractor.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Selcuk University Konya Selcuklu Turkey 42100

Sponsors and Collaborators

  • Selcuk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ozkan Onal, Professor, Selcuk University
ClinicalTrials.gov Identifier:
NCT04204681
Other Study ID Numbers:
  • 2018/335
First Posted:
Dec 19, 2019
Last Update Posted:
Dec 20, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ozkan Onal, Professor, Selcuk University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 20, 2019