The Jugular Vein Ultrasonography for Hydration Assessment in Healthy Participants - The THAP Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Variance analysis
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
- Interpersonal variance analysis(The whole ultrasound assessment will have a duration of maximum 45 minutes)
- Intrapersonal variance analysis(The whole ultrasound assessment will have a duration of maximum 45 minutes)
- Timepoint-dependent Intrapersonal variance analysis(The whole ultrasound assessment will have a duration of maximum 45 minutes)
- Duration of the US assessment(The whole ultrasound assessment will have a duration of maximum 45 minutes)
- Descriptive analysis(The whole ultrasound assessment will have a duration of maximum 45 minutes)