Bedside Ultrasound for Fluid Estimation

July 12, 2023 updated by: Gaurang Vaidya

Correlation of Internal Jugular and Inferior Vena Cava Diameter Variation on Bedside Ultrasound With Invasive Right Heart Catheterization

The study aims to standardize patient positioning during bedside ultrasound assessment of internal jugular vein (IJV) and correlate the results with invasive hemodynamics obtained immediately after. The study hypothesizes that the respiratory variation in the size of IJV, as estimated through ultrasound at bedside, is an accurate estimation of the patient's actual right atrial pressure estimated through right heart catheterization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Consecutive adult patients scheduled to undergo right heart catheterization.

Description

Inclusion Criteria:

  • Undergoing right heart catheterization

Exclusion Criteria:

  • Superior vena cava obstruction or compression
  • Severe tricuspid regurgitation
  • Mechanically ventilated patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Gaurang Vaidya, MD, University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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