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

Inferior Vena Cava Abnormality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04298216
• Other study ID #: 55097
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: Aaron Deng, BS
• Phone: (408)914-5494
• Email: adeng1[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Inferior Vena Cava Abnormality

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.