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OpenTrials
Completed

NCT Number: NCT05159063

Bedside Ultrasound for Fluid Estimation

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.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing right heart catheterization

Exclusion criteria

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

Treatment and study plan

Ultrasound Imaging

Device

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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. 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).

  6. 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.

Sponsors and collaborators

Lead sponsor

Gaurang Vaidya

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 15, 2021
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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