Inferior Vena Cava AbnormalityNCT04298216
Transhepatic Versus Subcostal Views to Assess Inferior Vena Cava Variation in Pediatric Patients
A study testing Ultrasound Analysis of Inferior Vena Cavae (IVC) in people with Inferior Vena Cava Abnormality, run by Stanford University.
Trial summary
Currently, in order to visualize the inferior vena cava (IVC) of the heart using ultrasound, physicians traditionally place the ultrasound probe onto the "Subcostal" area which is located below the chest in the upper abdomen area. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Inferior Vena Cava Abnormality
- What is being tested?
- Ultrasound Analysis of Inferior Vena Cavae (IVC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Nov 2026
- Phase
- Interventional
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Be between ages of 2-18 years of age
- Have parental consent
- located at an inpatient/outpatient facility at LPCH
- Be hemodynamically stable
Who cannot join
- Emergent Surgical Procedures
- BMI greater than 24
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Transhepatic Versus Subcostal Inferior Vena Cava Views to Assess Inferior Vena Cava Variation in Pediatric Patients
Currently, in order to visualize the inferior vena cava (IVC) of the heart using ultrasound, physicians traditionally place the ultrasound probe onto the "Subcostal" area which is located below the chest in the upper abdomen area. In this location, the pressure from the ultrasound probe is often uncomfortable for adults, and even more so for pediatric patients. Previous research and physician experience have demonstrated that it is possible to visualize the heart in the "transhepatic" area which is located under the arm on the side of the chest. By placing the ultrasound probe in this location, it is more comfortable for the patient when applying pressure, and this study aims to prove the effectiveness of visualizing the heart through this new location.
- Conditions
- Inferior Vena Cava Abnormality
- Being tested
- Ultrasound Analysis of Inferior Vena Cavae (IVC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Analysis of Inferior Vena Cavae (IVC)Diagnostic test
Novel Operators will attempt to visualize the Inferior Vena Cavae through two different views on the patient's body. The images taken will be interpreted by an expert ultrasound user to determine if the novel operator was successful in locating and evaluating the IVC.
| Study group | Role | What they receive |
|---|---|---|
| Assessment of Inferior Vena Cavae with Subcostal View | Active comparator | Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the subcostal region. Receives: Diagnostic Test: Ultrasound Analysis of Inferior Vena Cavae (IVC) |
| Assessment of Inferior Vena Cavae with Transhepatic View | Experimental | Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the transhepatic region. Receives: Diagnostic Test: Ultrasound Analysis of Inferior Vena Cavae (IVC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
Novel Operators will be timed from the point at which the probe is placed until the image has been and will be evaluated between both the control and experimental groups.
Measured: For the entirety of the ultrasound procedure.
Accuracy of the IVC Analysis
Novel Operators will be evaluated by the ultrasound expert who will confirm clinical success in locating the IVC.
Measured: For the entirety of the ultrasound procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Vena Cava AbnormalityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Ho Ban Tsui, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298216
- Sponsor's protocol ID
- 55097
- Status last verified
- Apr 2025
- First submitted
- 4 Mar 2020
- Last updated
- 1 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transhepatic Versus Subcostal Inferior Vena Cava Views to Assess Inferior Vena Cava Variation in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04298216
- Acronym / sponsor ID
- 55097
- Conditions
- Inferior Vena Cava Abnormality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 6 Mar 2020 (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.
Currently, in order to visualize the inferior vena cava (IVC) of the heart using ultrasound, physicians traditionally place the ultrasound probe onto the "Subcostal" area which is located below the chest in the upper abdomen area. In this location, the pressure from the ultrasound probe is often uncomfortable for adults, and even more so for pediatric patients. Previous research and physician experience have demonstrated that it is possible to visualize the heart in the "transhepatic" area which is located under the arm on the side of the chest. By placing the ultrasound probe in this location, it is more comfortable for the patient when applying pressure, and this study aims to prove the effectiveness of visualizing the heart through this new location.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessment of Inferior Vena Cavae with Subcostal View | Active comparator | Diagnostic Test: Ultrasound Analysis of Inferior Vena Cavae (IVC)Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the subcostal region. |
| Assessment of Inferior Vena Cavae with Transhepatic View | Experimental | Diagnostic Test: Ultrasound Analysis of Inferior Vena Cavae (IVC)Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the transhepatic region. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Be between ages of 2-18 years of age
- Have parental consent
- located at an inpatient/outpatient facility at LPCH
- Be hemodynamically stable
Key exclusion criteria (2 listed)
- Emergent Surgical Procedures
- BMI greater than 24
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Analysis of Inferior Vena Cavae (IVC)Novel Operators will attempt to visualize the Inferior Vena Cavae through two different views on the patient's body. The images taken will be interpreted by an expert ultrasound user to determine if the novel operator was successful in locating and evaluating the IVC. | Diagnostic test | Assessment of Inferior Vena Cavae with Subcostal View, Assessment of Inferior Vena Cavae with Transhepatic View |
Primary outcome
Time
Time frame: For the entirety of the ultrasound procedure.
Novel Operators will be timed from the point at which the probe is placed until the image has been and will be evaluated between both the control and experimental groups.
Accuracy of the IVC Analysis
Time frame: For the entirety of the ultrasound procedure.
Novel Operators will be evaluated by the ultrasound expert who will confirm clinical success in locating the IVC.
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 1 May 2025.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Analysis of Inferior Vena Cavae (IVC) in people with Inferior Vena Cava Abnormality, run by Stanford 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 4 inclusion and 2 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 1 May 2025. 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?
Contact Aaron Deng, BS ((408)914-5494, adeng1@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (time frame: For the entirety of the ultrasound procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2025.