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Tonsillar Retractor-induced Subacute Submassive Tongue Edema

S

Selcuk University

Status

Completed

Conditions

Tonsil Hypertrophy
Children, Only
Side Effects

Treatments

Diagnostic Test: Ultrasonography imaging

Study type

Observational

Funder types

Other

Identifiers

NCT04204681
2018/335

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

61 participants in 2 patient groups

Study
Description:
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.
Treatment:
Diagnostic Test: Ultrasonography imaging
Control
Description:
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.
Treatment:
Diagnostic Test: Ultrasonography imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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