NCT05159063

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

November 17, 2021

Last Update Submit

July 12, 2023

Conditions

Catheterization

Keywords

Internal jugular veinInferior vena cavaRight heart catheterization

Outcome Measures

Primary Outcomes (6)

  • Cross-sectional diameters of the internal jugular vein (IJV)

    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)

    Diameter variation index will be calculated as: (maximum diameter - minimum diameter)/ body surface area.

    5 minutes

  • Sniff collapsibility of IJV

    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)

    Maximum diameter - noted using M-mode (in mm) of the ultrasound machine.

    5 minutes

  • Cross-sectional diameters of the inferior vena cava (IVC)

    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)

    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

Study Arms (1)

Right heart catheterization

Device: Ultrasound imaging

Interventions

Ultrasound imagingDEVICE

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.

Right heart catheterization

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive adult patients scheduled to undergo right heart catheterization.

You may qualify if:

  • Undergoing right heart catheterization

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (1)

  • Vaidya GN, Kolodziej A, Stoner B, Galaviz JV, Cao X, Heier K, Thompson M, Birks E, Campbell K. Bedside ultrasound of the internal jugular vein to assess fluid status and right ventricular function: The POCUS-JVD study. Am J Emerg Med. 2023 Aug;70:151-156. doi: 10.1016/j.ajem.2023.05.042. Epub 2023 Jun 6.

    PMID: 37307660BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Gaurang Vaidya, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 15, 2021

Study Start

June 1, 2021

Primary Completion

March 30, 2022

Study Completion

April 30, 2022

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)