Back to resultsTranshepatic Versus Subcostal Views to Assess Inferior Vena Cava Variation in Pediatric Patients
Primary Purpose
Inferior Vena Cava Abnormality
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound Analysis of Inferior Vena Cavae (IVC)
Sponsored by
About this trial
This is an interventional diagnostic trial for Inferior Vena Cava Abnormality
Eligibility Criteria
Inclusion Criteria:
- Be between ages of 2-18 years of age
- Have parental consent
- located at an inpatient/outpatient facility at LPCH
- Be hemodynamically stable
Exclusion Criteria:
- Emergent Surgical Procedures
- BMI greater than 24
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Assessment of Inferior Vena Cavae with Subcostal View
Assessment of Inferior Vena Cavae with Transhepatic View
Arm Description
Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the subcostal region.
Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the transhepatic region.
Outcomes
Primary Outcome Measures
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.
Accuracy of the IVC Analysis
Novel Operators will be evaluated by the ultrasound expert who will confirm clinical success in locating the IVC.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04298216
Brief Title
Transhepatic Versus Subcostal Views to Assess Inferior Vena Cava Variation in Pediatric Patients
Official Title
Evaluation of Transhepatic Versus Subcostal Inferior Vena Cava Views to Assess Inferior Vena Cava Variation in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inferior Vena Cava Abnormality
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Assessment of Inferior Vena Cavae with Subcostal View
Arm Type
Active Comparator
Arm Description
Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the subcostal region.
Arm Title
Assessment of Inferior Vena Cavae with Transhepatic View
Arm Type
Experimental
Arm Description
Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the transhepatic region.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound Analysis of Inferior Vena Cavae (IVC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time
Description
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.
Time Frame
For the entirety of the ultrasound procedure.
Title
Accuracy of the IVC Analysis
Description
Novel Operators will be evaluated by the ultrasound expert who will confirm clinical success in locating the IVC.
Time Frame
For the entirety of the ultrasound procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be between ages of 2-18 years of age
Have parental consent
located at an inpatient/outpatient facility at LPCH
Be hemodynamically stable
Exclusion Criteria:
Emergent Surgical Procedures
BMI greater than 24
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Deng, BS
Phone
(408)914-5494
Email
adeng1@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transhepatic Versus Subcostal Views to Assess Inferior Vena Cava Variation in Pediatric Patients
We'll reach out to this number within 24 hrs