- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05159063
Bedside Ultrasound for Fluid Estimation
Correlation of Internal Jugular and Inferior Vena Cava Diameter Variation on Bedside Ultrasound With Invasive Right Heart Catheterization
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40506
- University of Kentucky
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Undergoing right heart catheterization
Exclusion Criteria:
- Superior vena cava obstruction or compression
- Severe tricuspid regurgitation
- Mechanically ventilated patients
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Right heart catheterization
|
Patients scheduled to undergo right heart catheterization (RHC) as their standard of care will be included in the study. The patient will be positioned supine at 0 degrees with normal restful breathing and patient looking straight up. After the right sternocleidomastoid muscle is identified, internal jugular vein (IJV) will be imaged at the apex of the triangle formed by the sternal and clavicular heads of the muscle. Similarly, the inferior vena cava (IVC) will be imaged at the caudal end of the sternum. The diameters of both the veins will be noted during normal respiration. The patients will then be asked to sniff and collapsibility of the veins will be noted. No pressure will be applied on the neck. The anticipated duration for image acquisition is between 5 to 10 minutes. The patients will undergo the scheduled RHC within 1 hour as scheduled. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cross-sectional diameters of the internal jugular vein (IJV)
Time Frame: 5 minutes
|
The respiratory variation percentage will assessed using M-mode of the ultrasound while the patient is breathing normally.
The maximum and minimum anteroposterior diameter will be noted using M-mode (in mm).
|
5 minutes
|
|
Cross-sectional diameters of the internal jugular vein (IJV)
Time Frame: 5 minutes
|
Diameter variation index will be calculated as: (maximum diameter - minimum diameter)/ body surface area.
|
5 minutes
|
|
Sniff collapsibility of IJV
Time Frame: 10 minutes
|
Complete collapse (0cm) of the anteroposterior diameter of IJV on sniff maneuver by the patient, as assessed by M-mode on the ultrasound.
|
10 minutes
|
|
Cross-sectional diameters of the inferior vena cava (IVC)
Time Frame: 5 minutes
|
Maximum diameter - noted using M-mode (in mm) of the ultrasound machine.
|
5 minutes
|
|
Cross-sectional diameters of the inferior vena cava (IVC)
Time Frame: 5 minutes
|
Respiratory variation - assessed using M-mode of the ultrasound while the patient is breathing normally.
This will be calculated as (maximum diameter - minimum diameter)/maximum diameter and expressed as a percentage.
The maximum and minimum diameters will be noted using M-mode (in mm).
|
5 minutes
|
|
Cross-sectional diameters of the inferior vena cava (IVC)
Time Frame: 5 minutes
|
Sniff collapsibility - Complete collapse (0cm) of the cross sectional diameter of IVC on sniff maneuver by the patient, as assessed by M-mode of the ultrasound.
|
5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gaurang Vaidya, MD, University of Kentucky
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 67340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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