The Jugular Vein Ultrasonography for Hydration Assessment in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Dehydration; Hypervolemia; Water Balance Disorders
• Intervention / Treatment: Diagnostic test: measurement of IJV-height

Detailed Description

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:

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

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Recruitment will take place at university hospital of Basel through flyers and word of mouth addressed to healthy visitors and employees.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variance analysis	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	The whole ultrasound assessment will have a duration of maximum 45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interpersonal variance analysis	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	The whole ultrasound assessment will have a duration of maximum 45 minutes
Intrapersonal variance analysis	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	The whole ultrasound assessment will have a duration of maximum 45 minutes
Timepoint-dependent Intrapersonal variance analysis	Intrapersonal variance analysis according to timepoint of US-assessment (first 15 participants vs last 15 participants)	The whole ultrasound assessment will have a duration of maximum 45 minutes
Duration of the US assessment	Duration of the US assessment (minutes): interpersonal and intrapersonal variance analysis, protocol 1 vs 2 vs 3	The whole ultrasound assessment will have a duration of maximum 45 minutes
Descriptive analysis	Descriptive analysis of analogue Visual Analogue Scale (VAS) Score data about acceptance of the 3 different US assessment protocols	The whole ultrasound assessment will have a duration of maximum 45 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Laura Potasso, Dr. med. sc., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Actual): December 3, 2024
• Study Completion (Actual): December 3, 2024

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Hydration; internal jugular vein; jugular vein pressure; non-invasive hydration status assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: 2024-01640; kt24Potasso

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: No