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Completed

NCT Number: NCT06706960

The Jugular Vein Ultrasonography for Hydration Assessment in Healthy Participants

The aim of this cross-sectional, descriptive analysis is to compare 3 different ultrasound-based protocols to measure the internal jugular vein pressure (uJVP) in healthy individuals.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

Proper hydration is crucial for health, and imbalances-like dehydration or fluid overload-can cause serious health problems including increased morbidity, hospitalization rate, and even mortality. Currently, assessing hydration is challenging, and there is no standardized method in clinical use.

Ultrasound (US) of the internal jugular vein (IJV) and ultrasound-guided estimation of jugular venous pressure (uJVP) is a promising, non-invasive method to assess the hydration status. Several measure methods have been described, however, there is no univocal protocol for US IJV-assessment.

In this study, three existing protocols including 4 measurements are compared to measure uJVP, which reflects the body's fluid balance. The study aims to find out which method is most accurate, easy to perform, and consistent when done by the same or different medical professionals. They will also look at how long each method takes and how acceptable these tests are to participants.

The study is performed in healthy individuals and all 4 measurements are applied cross-sectional during one visit. The whole ultrasound assessment will have a duration of maximum 45 minutes.

For all protocols, uJVP will be calculated by measuring with a ruler the vertical distance between IJV-height and sternal angle (cm) and then adding 5cm to this value.

Protocol 1: IJV tapering portion is portrayed in a transverse view. The IJV height is marked and measured as soon as IJV is smaller than Common Carotid Artery (CCA) throughout the whole respiratory cycle.

Protocol 2: IJV tapering portion is portrayed in a transverse view. The IJV height is marked and measured as soon as IJV is completely collapsed throughout the whole respiratory cycle.

Protocol 3: IJV tapering portion is portrayed in a longitudinal view. The IJV height at the end of expiration is marked and measured at the following two positions:

  • Measurement 1: at the very end of the tapering portion (collapsing point / top of pulsation).
  • Measurement 2: at the beginning of the tapering portion (taper point).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults aged 18 years or older, 15 women and 15 men.

Exclusion criteria

  • Major cardiovascular event in the last 3 months
  • Pregnant or lactating women
  • Heart failure of any grade
  • Kidney failure
  • Thrombosis V. jugularis interna
  • Atrial Fibrillation
  • Valves impairment
  • Uncontrolled Diabetes mellitus
  • Uncontrolled Diabetes insipidus (AVP resistance or deficiency)
  • Respiratory Distress of any grade
  • Signs/Symptoms of volume loss (diarrhea, vomiting, bleeding) in the past 3 days
  • Medication: Angiotensin-converting enzyme inhibitors, Angiotensin receptor blockers, any diuretic therapy
  • Inability to follow procedures or insufficient knowledge of project language.
  • Inability to give consent
  • Abnormal vital signs: tachycardia > 90/min, systolic blood pressure < 90 mmHg

Treatment and study plan

measurement of IJV-height

Diagnostic Test

Protocol 1: IJV tapering portion is portrayed in a transverse view. With a skin marker, the IJV height is marked and measured as soon as IJV is smaller than CCA throughout the whole respiratory cycle.

Protocol 2: IJV tapering portion is portrayed in a transverse view. With a skin marker, the IJV height is marked and measured as soon as IJV is completely collapsed throughout the whole respiratory cycle.

Protocol 3: IJV tapering portion is portrayed in a longitudinal view. With a skin marker, the IJV height at the end of expiration is marked and measured at the following two positions:

  • Measurement 1: at the very end of the tapering portion (collapsing point / top of pulsation).
  • Measurement 2: at the beginning of the tapering portion (taper point).

Primary outcomes

  1. Variance analysis

    Time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes

    Percentage of participants differing > 1 Standard Deviation (SD) from the expected value of Ultrasound-guided Jugular Venous Pressure (uJVP) measured in cm for each of the 3 protocols

Secondary outcomes

  1. Interpersonal variance analysis

    Time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes

    Interpersonal variance analysis of the results for uJVP (cm) for each of the 3 different protocols, as well as for collapsibility index (%) and Jugular Vein Diameter (JVD) ratio

  2. Intrapersonal variance analysis

    Time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes

    Intrapersonal variance analysis of the results for uJVP (cm) for each of the 3 different protocols, as well as for collapsibility index (%) and JVD ratio

  3. Timepoint-dependent Intrapersonal variance analysis

    Time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes

    Intrapersonal variance analysis according to timepoint of US-assessment (first 15 participants vs last 15 participants)

  4. Duration of the US assessment

    Time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes

    Duration of the US assessment (minutes): interpersonal and intrapersonal variance analysis, protocol 1 vs 2 vs 3

  5. Descriptive analysis

    Time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes

    Descriptive analysis of analogue Visual Analogue Scale (VAS) Score data about acceptance of the 3 different US assessment protocols

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

The Jugular Vein Ultrasonography for Hydration Assessment in Healthy Participants - The THAP Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 27, 2024
Registry last updated
Feb 3, 2025

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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