- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07676968
IVC Window Agreement Study
Are Subcostal, Transhepatic, and Coronal Windows Interchangeable for IVC Ultrasonography? A Multicenter Prospective Agreement Study
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The existing literature presents conflicting results regarding the interchangeability of these windows. Several studies report significant discrepancies between SC and RC measurements, while others demonstrate strong agreement. Direct comparison of the SC and aTH windows has received considerably less attention, with only a single prospective study to date reporting reliable agreement between these approaches under standardized imaging criteria.
Methodological heterogeneity, most likely arising from an unstandardized imaging technique, underlies much of the observed discordance. As a result, clinicians lack clear guidance on whether alternative windows can reliably substitute for the SC approach across diverse clinical settings.
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Adult patients (≥18 years) requiring ultrasonographic assessment of intravascular volume status will be consecutively enrolled.
Exclusion Criteria:
- Pregnancy, refusal to participate, and inability to obtain any IVC image via the SC approach.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Patients who need volume status assessment
Patients who need volume status assessment in the emergency, critical, or acute care settings
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The intermethod agreement of IVC diameter and collapsibility index measurements
Tidsramme: 90 days
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The intermethod agreement of IVC diameter and collapsibility index measurements obtained from the subcostal (SC), anterior transhepatic (aTH), and right coronal (RC) ultrasonographic windows under a standardized imaging protocol, and to determine whether aTH and RC windows can serve as reliable alternatives to the SC approach across diverse clinical settings and operator profiles.
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90 days
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- La Via L, Astuto M, Dezio V, Muscara L, Palella S, Zawadka M, Vignon P, Sanfilippo F. Agreement between subcostal and transhepatic longitudinal imaging of the inferior vena cava for the evaluation of fluid responsiveness: A systematic review. J Crit Care. 2022 Oct;71:154108. doi: 10.1016/j.jcrc.2022.154108. Epub 2022 Jul 5.
- Kulkarni AP, Janarthanan S, Harish MM, Suhail S, Chaudhari H, Agarwal V, Patil VP, Divatia JV. Agreement between inferior vena cava diameter measurements by subxiphoid versus transhepatic views. Indian J Crit Care Med. 2015 Dec;19(12):719-22. doi: 10.4103/0972-5229.171390.
- Albayrak AK, Aslaner MA, Korkak OF, Bildik F. Reliability of Alternative Sonographic Approaches for Inferior Vena Cava: Comparison of Subcostal, Transhepatic, and Coronal Windows. J Emerg Med. 2026 Jan;80:64-73. doi: 10.1016/j.jemermed.2025.10.024. Epub 2025 Oct 23.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Gazi U - IVC
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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