HypervolemiaAIJV-INCT06591234
Reliability of Internal Jugular Ultrasound : an Observational Transversal Study Conducted Using Images Registered From Patients (AIJV-I)
An observational study of Hypervolemia and Hypovolemia, run by Maggiore Bellaria Hospital, Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypervolemia, Hypovolemia
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2024to 31 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
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients, admitted to the Medicine Department of Hospital Maggiore in Bologna and eight expert sonographers
Who cannot join
- impossibility in providing consent, presence of central venous catheter in the internal jugular vein, thrombosis of the vein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Study on the Reliability of Four Ultrasound Measures : the Antero-posterior Diameter , the End-exipratory Area , the Aspect Ratio and the Collapsibility Index of Internal Jugular Vein Evaluated on Images Recorded From Patients Admitted to Four Medicine Departments
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 ?
Read the detailed description
Dear Mrs/s, We intend to carry out medical scientific research in this Centre. It is a study of observation.. This study aims to measure the reliability (variability in recording measurements between two or more operators) of a new method, the ultrasound of a vein in the neck, called the internal jugular vein. This method could be used to better assess congestion (accumulation of fluid in the lung or tissues: vessels and skin) or lack of fluid in the veins, both possible causes of hospitalization.
We are proposing to you to participate in this study because you are hospitalized in the ward and this method allows to understand, together with other elements, the state of \"volemia\" (the amount of liquids present in your veins).
We decided to carry out this study because we would like to verify if the ultrasound of the internal jugular vein is reliable, that is it can be used by several operators without variations in the measurements . This would allow, after further studies, to use it in clinical practice for the management of people who may need fluid infusion or therapies to increase fluid removal.
The study aims to evaluate the reliability (variability in recording measurements between two or more operators) of ultrasound of a vein of the neck, called internal jugular vein In particular we would like to understand if there is a variability in the execution of the ultrasound of the jugular vein between several operators- doctors simultaneously to the same patient. In fact, this method is not currently used in current clinical practice, but if we demonstrate that it is reliable (ie more operators record the same measurements on the same patient , without variations), after further confirmation studies have been conducted , could be used in clinical practice. Its use could, in our view, improve the management of many situations, as it would allow doctors to understand whether the person examined is suffering from \"congestion\", that is, accumulation of water in the lungs and tissues or lack of fluids. This would allow the doctor to take appropriate therapies to reduce congestion or increase fluid.
During the hospitalization, on one occasion, will be submitted to an ultrasound examination of the neck on the right , simultaneously by two or three operators (doctors) . Each operator's examination should take about 10-15 minutes. So the time you spend on it should be 20-30 minutes. The examination will be carried out in bed, in his room with the back tilted 45 degrees and the neck slightly turned to the left.
The necessary treatment and examinations will be carried out and the reason for his admission will be continued.
There is no health risk, as ultrasound is a non-invasive examination based on ultrasound. The only discomfort is to be subjected for about thirty minutes to two or three consecutive examinations. There are no direct benefits to the participants. The study is oriented towards acquiring more scientific knowledge.
- Conditions
- Hypervolemia, Hypovolemia
- Keywords
- reliability, internal jugular vein, ultrasound
- Medical subject headings
- Edema, Hypovolemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of recording (within 2 months of starting the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Sep 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypervolemiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maggiore Bellaria Hospital, Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Parenti, Maggiore Bellaria Hospital, Bologna
- Investigators
- Nicola Parenti, MD, Principal investigator, Medicina Interna Hospital Maggiore Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591234
- Sponsor's protocol ID
- 725-2023-OSS-AUSLBObis
- Acronym
- AIJV-I
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will share the study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on the Reliability of Four Ultrasound Measures : the Antero-posterior Diameter , the End-exipratory Area , the Aspect Ratio and the Collapsibility Index of Internal Jugular Vein Evaluated on Images Recorded From Patients Admitted to Four Medicine Departments
- ClinicalTrials.gov ID
- NCT06591234
- Acronym / sponsor ID
- AIJV-I / 725-2023-OSS-AUSLBObis
- Conditions
- Hypervolemia, Hypovolemia
- Keywords
- reliability, internal jugular vein, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maggiore Bellaria Hospital, BolognaUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Sep 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 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 ?
Detailed description
Dear Mrs/s, We intend to carry out medical scientific research in this Centre. It is a study of observation.. This study aims to measure the reliability (variability in recording measurements between two or more operators) of a new method, the ultrasound of a vein in the neck, called the internal jugular vein. This method could be used to better assess congestion (accumulation of fluid in the lung or tissues: vessels and skin) or lack of fluid in the veins, both possible causes of hospitalization.
We are proposing to you to participate in this study because you are hospitalized in the ward and this method allows to understand, together with other elements, the state of \"volemia\" (the amount of liquids present in your veins).
We decided to carry out this study because we would like to verify if the ultrasound of the internal jugular vein is reliable, that is it can be used by several operators without variations in the measurements . This would allow, after further studies, to use it in clinical practice for the management of people who may need fluid infusion or therapies to increase fluid removal.
The study aims to evaluate the reliability (variability in recording measurements between two or more operators) of ultrasound of a vein of the neck, called internal jugular vein In particular we would like to understand if there is a variability in the execution of the ultrasound of the jugular vein between several operators- doctors simultaneously to the same patient. In fact, this method is not currently used in current clinical practice, but if we demonstrate that it is reliable (ie more operators record the same measurements on the same patient , without variations), after further confirmation studies have been conducted , could be used in clinical practice. Its use could, in our view, improve the management of many situations, as it would allow doctors to understand whether the person examined is suffering from \"congestion\", that is, accumulation of water in the lungs and tissues or lack of fluids. This would allow the doctor to take appropriate therapies to reduce congestion or increase fluid.
During the hospitalization, on one occasion, will be submitted to an ultrasound examination of the neck on the right , simultaneously by two or three operators (doctors) . Each operator's examination should take about 10-15 minutes. So the time you spend on it should be 20-30 minutes. The examination will be carried out in bed, in his room with the back tilted 45 degrees and the neck slightly turned to the left.
The necessary treatment and examinations will be carried out and the reason for his admission will be continued.
There is no health risk, as ultrasound is a non-invasive examination based on ultrasound. The only discomfort is to be subjected for about thirty minutes to two or three consecutive examinations. There are no direct benefits to the participants. The study is oriented towards acquiring more scientific knowledge.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients, admitted to the Medicine Department of Hospital Maggiore in Bologna and eight expert sonographers
Key exclusion criteria (1 listed)
- impossibility in providing consent, presence of central venous catheter in the internal jugular vein, thrombosis of the vein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter-rater reliability of Internal Jugular Vein Ultrasound measures
Time frame: From enrollment to the end of recording (within 2 months of starting the study)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Thelink of the Hospital of PILink provided by the sponsor.
- Individual participant dataSharing planned: Yes. I will share the study protocol.
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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.
Nicola Parenti, MD principal investigator
Medicina Interna Hospital Maggiore Bologna
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 Hypervolemia and Hypovolemia, run by Maggiore Bellaria Hospital, Bologna at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Italy. 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?
Results are not available in the source record.
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?
Inter-rater reliability of Internal Jugular Vein Ultrasound measures (time frame: From enrollment to the end of recording (within 2 months of starting the study)). 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 19 Sep 2024.