The Jugular Vein Ultrasonography for Hydration Assessment in Healthy Participants

NCT06706960 | Completed

• 1 other identifier: 2024-01640; kt24Potasso
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Water Balance Disorders; Dehydration; Hypervolemia

Keywords

jugular vein pressure; internal jugular vein; non-invasive hydration status assessment; Hydration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Interventions

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: 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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Dehydration; Edema

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Laura Potasso, Dr. med. sc.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 27, 2024
• Study Start: October 22, 2024
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: February 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)