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
NCT number | NCT04204681 |
Other study ID # | 2018/335 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2018 |
Est. completion date | September 1, 2019 |
Verified date | December 2019 |
Source | Selcuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Selcuk University | Konya | Selcuklu |
Lead Sponsor | Collaborator |
---|---|
Selcuk University |
Turkey,
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) |
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