Tonsillar Retractor-induced Subacute Submassive Tongue Edema
18. december 2019 opdateret af: Ozkan Onal, Selcuk University
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
61
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Selcuklu
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Konya, Selcuklu, Kalkun, 42100
- Selcuk University
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 år til 16 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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.
|
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.
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|
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from preoperative measurement to postoperative measurement in tongue area on the ultrasonography imaging.
Tidsramme: 2018-2019 (6 months)
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This study aimed to evaluate the change from baseline in tongue area on the ultrasonography imaging due to the tonsillar retractor.
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2018-2019 (6 months)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Detection of edema formation in tongue by using ultrasonography imaging.
Tidsramme: 2018-2019 (6 months)
|
This study aimed to measure and detect the tongue edema by using ultrasonography imaging due to the tonsillar retractor.
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2018-2019 (6 months)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2018
Primær færdiggørelse (Faktiske)
1. april 2019
Studieafslutning (Faktiske)
1. september 2019
Datoer for studieregistrering
Først indsendt
17. december 2019
Først indsendt, der opfyldte QC-kriterier
17. december 2019
Først opslået (Faktiske)
19. december 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. december 2019
Sidst verificeret
1. december 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018/335
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