Reliability of Internal Jugular Ultrasound : an Observational Transversal Study Conducted Using Images Registered From Patients (AIJV-I)

NCT06591234 | Active Not Recruiting

• 1 other identifier: 725-2023-OSS-AUSLBObis
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to test the inter-rater reliability among a group of ultrasound measurements of internal jugular vein using a group of images, registered in several acoustic views of neck of patients admitted in Medicine Department. The main questions it aims to answer is: are there differences in recording echographic measurements of the internal jugular vein between different sonographers ?

Conditions

Hypervolemia; Hypovolemia

Keywords

reliability; internal jugular vein; ultrasound

Outcome Measures

Primary Outcomes (1)

• Inter-rater reliability of Internal Jugular Vein Ultrasound measures

  We will measure the variability in recording, among 8 sonographers, of 4 Ultrasound measures of Internal Jugular Vein : the antero-posterior diameters, the area, the aspect ratio and the collapsibility index

  From enrollment to the end of recording (within 2 months of starting the study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will include 2 populations: Patients admitted , for any causes, to the Medicine Department (we will record a group of 6 images that will be used by the sonographers). Sonographers from Medicine Department

You may qualify if:

• patients, admitted to the Medicine Department of Hospital Maggiore in Bologna and eight expert sonographers

You may not qualify if:

• impossibility in providing consent, presence of central venous catheter in the internal jugular vein, thrombosis of the vein

Sponsors & Collaborators

• Maggiore Bellaria Hospital, Bologna: lead

Study Sites (1)

Hospital Maggiore

Bologna, 40125, Italy

Location

Related Links

• Thelink of the Hospital of PI

MeSH Terms

Conditions

Edema; Hypovolemia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Nicola Parenti, MD

  Medicina Interna Hospital Maggiore Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: September 5, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: The criteria that must be met in order for data to be shared are: Clinical Researchers who conduct independent research Analyses on diagnostic accuracy of ultrasound methods Statistical methods for those analyses must be not approved by independent review. A proposal that describes planned analyses must be submitted and a data sharing agreement must be signed. Those documents can be submitted by sending a mail to nicola.parenti@ausl.bologna.it

Locations

IT (1)