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

NCT04298216 | Not Yet Recruiting

• 1 other identifier: 55097
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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.

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.

Diagnostic Test: Ultrasound Analysis of Inferior Vena Cavae (IVC)

Interventions

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.

Assessment of Inferior Vena Cavae with Subcostal View; Assessment of Inferior Vena Cavae with Transhepatic View

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Emergent Surgical Procedures
• BMI greater than 24

Sponsors & Collaborators

• Stanford University: lead

Central Study Contacts

Aaron Deng, BS

CONTACT

(408)914-5494; adeng1@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share