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

Studies

Study First Submitted Date 2020-03-04
Study First Posted Date 2020-03-06
Last Update Posted Date 2023-04-18
Start Month Year January 2024
Primary Completion Month Year December 2024
Verification Month Year April 2023
Verification Date 2023-04-30
Last Update Posted Date 2023-04-18

Conditions

Sequence: 52282398
Name Inferior Vena Cava Abnormality
Downcase Name inferior vena cava abnormality

Id Information

Sequence: 40238923
Id Source org_study_id
Id Value 55097

Design Groups

Sequence: 55717350 Sequence: 55717351
Group Type Active Comparator Group Type Experimental
Title Assessment of Inferior Vena Cavae with Subcostal View Title Assessment of Inferior Vena Cavae with Transhepatic View
Description Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the subcostal region. Description Patients will have a novel operator attempt to visualize their Inferior Vena Cavae with the probe placed in the transhepatic region.

Interventions

Sequence: 52594528
Intervention Type Diagnostic Test
Name Ultrasound Analysis of Inferior Vena Cavae (IVC)
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.

Design Outcomes

Sequence: 177788298 Sequence: 177788299
Outcome Type primary Outcome Type primary
Measure Time Measure Accuracy of the IVC Analysis
Time Frame For the entirety of the ultrasound procedure. Time Frame For the entirety of the ultrasound procedure.
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. Description Novel Operators will be evaluated by the ultrasound expert who will confirm clinical success in locating the IVC.

Browse Conditions

Sequence: 193912022
Mesh Term Congenital Abnormalities
Downcase Mesh Term congenital abnormalities
Mesh Type mesh-list

Sponsors

Sequence: 48423281
Agency Class OTHER
Lead Or Collaborator lead
Name Stanford University

Central Contacts

Sequence: 12035824
Contact Type primary
Name Aaron Deng, BS
Phone (408)914-5494
Email adeng1@stanford.edu
Role Contact

Design Group Interventions

Sequence: 68299249 Sequence: 68299250
Design Group Id 55717350 Design Group Id 55717351
Intervention Id 52594528 Intervention Id 52594528

Eligibilities

Sequence: 30829955
Gender All
Minimum Age 2 Years
Maximum Age 18 Years
Healthy Volunteers Accepts Healthy Volunteers
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
Adult True
Child True
Older Adult False

Calculated Values

Sequence: 254131427
Registered In Calendar Year 2020
Were Results Reported False
Has Single Facility False
Minimum Age Num 2
Maximum Age Num 18
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2

Designs

Sequence: 30575877
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Diagnostic
Time Perspective
Masking Single
Subject Masked True

Responsible Parties

Sequence: 28942285
Responsible Party Type Principal Investigator
Name Chi-Ho Ban Tsui
Title Principal Investigator
Affiliation Stanford University