Water Balance DisordersNCT06706960
The Jugular Vein Ultrasonography for Hydration Assessment in Healthy Participants
An observational study of Water Balance Disorders and Dehydration, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Water Balance Disorders, Dehydration, Hypervolemia
- What is being tested?
- measurement of IJV-height
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Oct 2024to 3 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment will take place at university hospital of Basel through flyers and word of mouth addressed to healthy visitors and employees.
Who may be able to join
- 1. Healthy adults aged 18 years or older, 15 women and 15 men.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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).
- Conditions
- Water Balance Disorders, Dehydration, Hypervolemia
- Being tested
- measurement of IJV-height
- Keywords
- jugular vein pressure, internal jugular vein, non-invasive hydration status assessment, Hydration
- Medical subject headings
- Dehydration, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of IJV-heightDiagnostic 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The whole ultrasound assessment will have a duration of maximum 45 minutes
Secondary outcomes (5)
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: The whole ultrasound assessment will have a duration of maximum 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start22 Oct 2024
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water Balance DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Potasso, Dr. med. sc., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706960
- Sponsor's protocol ID
- 2024-01640; kt24Potasso
- Status last verified
- Dec 2024
- First submitted
- 22 Nov 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Jugular Vein Ultrasonography for Hydration Assessment in Healthy Participants - The THAP Study
- ClinicalTrials.gov ID
- NCT06706960
- Acronym / sponsor ID
- 2024-01640; kt24Potasso
- Conditions
- Water Balance Disorders, Dehydration, Hypervolemia
- Keywords
- jugular vein pressure, internal jugular vein, non-invasive hydration status assessment, Hydration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will take place at university hospital of Basel through flyers and word of mouth addressed to healthy visitors and employees.
Key inclusion criteria (1 listed)
- 1. Healthy adults aged 18 years or older, 15 women and 15 men.
Key exclusion criteria (15 listed)
- Major cardiovascular event in the last 3 months
- Pregnant or lactating women
- Heart failure of any grade
- Kidney failure
- Thrombosis V. jugularis interna
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of IJV-heightProtocol 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: 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). | Diagnostic test | – |
Primary outcome
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
5 secondary outcomes
Interpersonal variance analysis
Time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes
Intrapersonal variance analysis
Time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes
Timepoint-dependent Intrapersonal variance analysis
Time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes
Duration of the US assessment
Time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes
Descriptive analysis
Time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Potasso, Dr. med. sc. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Water Balance Disorders and Dehydration, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variance analysis (time frame: The whole ultrasound assessment will have a duration of maximum 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.