Transhepatic Versus Subcostal Views to Assess Inferior Vena Cava Variation in Pediatric Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inferior Vena Cava Abnormality
• Intervention / Treatment: Diagnostic test: Ultrasound Analysis of Inferior Vena Cavae (IVC)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aaron Deng, BS; Phone Number: (408)914-5494; Email: adeng1@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Be between ages of 2-18 years of age
2. Have parental consent
3. located at an inpatient/outpatient facility at LPCH
4. Be hemodynamically stable

Exclusion Criteria:

1. Emergent Surgical Procedures
2. BMI greater than 24

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Assessment of Inferior Vena Cavae with Subcostal View; Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the subcostal region.	Diagnostic test: 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.
Experimental: Assessment of Inferior Vena Cavae with Transhepatic View; Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the transhepatic region.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	For the entirety of the ultrasound procedure.

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 55097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No