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

Overview

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.

Full Title of Study: “Evaluation of Transhepatic Versus Subcostal Inferior Vena Cava Views to Assess Inferior Vena Cava Variation in Pediatric Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2024

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chi-Ho Ban Tsui, Principal Investigator – Stanford University
  • Overall Contact(s)
    • Aaron Deng, BS, (408)914-5494, adeng1@stanford.edu

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