- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04205253
Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue
18. december 2019 opdateret af: Ozkan Onal, Selcuk University
Is it Possible That Direct Rigid Laryngoscope-related Ischemia-Reperfusion Injury Occurs in the Tongue During Suspension Laryngoscopy as Detected by Ultrasonography: A Prospective Controlled Study
This study aimed to detect tongue edema associated with the pressure exerted by a rigid direct laryngoscope by measuring the tongue area using USG in patients undergoing suspension laryngoscopy (SL) procedures.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Suspension laryngoscopy (SL) is a surgical procedure for both diagnostic and therapeutic purposes.
In this procedure, a rigid direct laryngoscope is inserted orally, and the tongue and the base of the tongue are compressed.The tongue is an ideal organ for evaluation with ultrasonography.
This study aimed to detect the occurrence of tongue edema through ultrasonography examination due to the rigid direct laryngoscope in SL procedures.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
64
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Selcuklu
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Konya, Selcuklu, Kalkun, 42100
- Selcuk University
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Konya, Selcuklu, Kalkun, 42100
- Selcen Celik
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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
20 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients aged 20 years or older who will undergo suspension laryngoscopy procedures or who did not need suspension larygoscopy procedures.
Beskrivelse
Study group
Inclusion Criteria:
- Patients aged 20 years or older
- Patients who undergo suspension laryngoscope procedure
Exclusion Criteria:
- refusal to participate
- age of <20 years
- history of syndromal craniofacial abnormalities
- occurrence of tongue masses
- history of craniofacial surgery
- history of burns, trauma or radiotherapy involving the head and neck region
- neurologic disorders and patients with obstructive sleep apnea syndrome (OSAS)
- active inflammation in the head and neck region
- cervical rigidity limiting neck flexion and head extension
Control group
Inclusion Criteria:
Patients aged 20 years or older Patients who did not need suspension laryngoscopy and any head and neck procedures
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 |
---|---|
Study
The first group is the study group.
Patients aged 20 years or older and were to undergo suspension laryngoscopy procedure were eligible for inclusion in this group.
Tongue areas were measured twice by submental USG.
The first measurements (TA1) were done immediately after endotracheal intubation before introducing the rigid direct laryngoscope, whereas the second measurements (TA2) were done after the SL procedure and after removing the rigid direct laryngoscope just before extubation.The difference between TA2 and TA1 (i.e., TA2-TA1) were used to define the occurrence of tongue edema as study group.
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This study aimed to evaluate the tongue areas and compare the tongue areas before the implementation of rigid direct laryngoscope and after the rigid direct laryngoscope.
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Control
The second group was the control group, which included patients who did not need SL and any head and neck procedures.The tongue areas of these patients were measured twice by submental USG as in the study group.
The TA1 measurements were done immediately after endotracheal intubation, whereas the TA2 measurements were done at the end of the surgical procedure just before extubation.
The difference between TA2 and TA1 (i.e., TA2-TA1) were used to define the occurrence of tongue edema as study group.
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This study aimed to evaluate the tongue areas and compare the tongue areas before the implementation of rigid direct laryngoscope and after the rigid direct laryngoscope.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Rate of change in tongue area.
Tidsramme: 2018-2019 (6 months)
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This study aimed to measure the change in tongue areas before and after the implementation of rigid direct laryngoscope by using ultrasonography imaging.
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2018-2019 (6 months)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Rate of formation in tongue edema.
Tidsramme: 2018 (6 months)
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This study aimed to measure the formation of tongue edema due to the rigid direct laryngoscope by using ultrasonography imaging.
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2018 (6 months)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. oktober 2018
Primær færdiggørelse (Faktiske)
1. april 2019
Studieafslutning (Faktiske)
1. april 2019
Datoer for studieregistrering
Først indsendt
17. december 2019
Først indsendt, der opfyldte QC-kriterier
18. december 2019
Først opslået (Faktiske)
19. december 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. december 2019
Sidst verificeret
1. december 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018/330
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data has been planned to share after publishing as a article in a journal.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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