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

NCT ID: NCT04298216

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ultrasound Analysis of Inferior Vena Cavae (IVC)

Intervention Type: 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 Transhepatic View

Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the transhepatic region.

Group Type: EXPERIMENTAL

Ultrasound Analysis of Inferior Vena Cavae (IVC)

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Chi-Ho Ban Tsui

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Aaron Deng, BS

Role: CONTACT

adeng1@stanford.edu

(408)914-5494

Other Identifiers

55097

Identifier Type: -

Identifier Source: org_study_id