- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07676968
IVC Window Agreement Study
Are Subcostal, Transhepatic, and Coronal Windows Interchangeable for IVC Ultrasonography? A Multicenter Prospective Agreement Study
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Patients who need volume status assessment
Patients who need volume status assessment in the emergency, critical, or acute care settings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The intermethod agreement of IVC diameter and collapsibility index measurements
Time Frame: 90 days
|
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.
|
90 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Gazi U - IVC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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