Emergency CareNCT07676968
IVC Window Agreement Study
An observational study of Emergency Care and Volume Assessment, run by Gazi University.
Trial summary
Ultrasonographic evaluation of the inferior vena cava (IVC) is widely used in emergency and critical care settings for noninvasive assessment of intravascular volume status. The subcostal (SC) window is the standard approach; however, it is frequently limited by obesity, bowel distension, or postoperative anatomical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Care, Volume Assessment, POCUS
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) requiring ultrasonographic assessment of intravascular volume status in the emergency departments, intensive care units, and other acute care settings.
Who may be able to join
- Adult patients (≥18 years) requiring ultrasonographic assessment of intravascular volume status will be consecutively enrolled.
Who cannot join
- Pregnancy, refusal to participate, and inability to obtain any IVC image via the SC approach.
About this study
Official title: Are Subcostal, Transhepatic, and Coronal Windows Interchangeable for IVC Ultrasonography? A Multicenter Prospective Agreement Study
Ultrasonographic evaluation of the inferior vena cava (IVC) is widely used in emergency and critical care settings for noninvasive assessment of intravascular volume status. The subcostal (SC) window is the standard approach; however, it is frequently limited by obesity, bowel distension, or postoperative anatomical changes. In such cases, the right coronal (RC) and anterior transhepatic (aTH) windows have been proposed as alternatives.
Read the 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.
- Conditions
- Emergency Care, Volume Assessment, POCUS, Venous Hemodynamics
- Keywords
- inferior vena cava, ultrasonography, volume status, POCUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who need volume status assessment | Patients who need volume status assessment in the emergency, critical, or acute care settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intermethod agreement of IVC diameter and collapsibility index measurements
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Emergency CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Aslaner, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676968
- Sponsor's protocol ID
- Gazi U - IVC
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35797826Kulkarni 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.
PubMed 26816446Albayrak 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.
PubMed 41270322
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Subcostal, Transhepatic, and Coronal Windows Interchangeable for IVC Ultrasonography? A Multicenter Prospective Agreement Study
- ClinicalTrials.gov ID
- NCT07676968
- Acronym / sponsor ID
- Gazi U - IVC
- Conditions
- Emergency Care, Volume Assessment, POCUS, Venous Hemodynamics
- Keywords
- inferior vena cava, ultrasonography, volume status, POCUS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ultrasonographic evaluation of the inferior vena cava (IVC) is widely used in emergency and critical care settings for noninvasive assessment of intravascular volume status. The subcostal (SC) window is the standard approach; however, it is frequently limited by obesity, bowel distension, or postoperative anatomical changes. In such cases, the right coronal (RC) and anterior transhepatic (aTH) windows have been proposed as alternatives.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who need volume status assessment | – | –Patients who need volume status assessment in the emergency, critical, or acute care settings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) requiring ultrasonographic assessment of intravascular volume status in the emergency departments, intensive care units, and other acute care settings.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) requiring ultrasonographic assessment of intravascular volume status will be consecutively enrolled.
Key exclusion criteria (1 listed)
- Pregnancy, refusal to participate, and inability to obtain any IVC image via the SC approach.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Results publication: PubMed 35797826La 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.
- Results publication: PubMed 26816446Kulkarni 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.
- Results publication: PubMed 41270322Albayrak 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Care and Volume Assessment, run by Gazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intermethod agreement of IVC diameter and collapsibility index measurements (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07676968, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.