TransfusionJUVIANCT03484052
Place of Jugular Ultrasound in the Evaluation of the Volemia by a Clinician Doctor in Routine Care
A study testing Jugular ultrasound in people with Transfusion, run by Rennes University Hospital at 1 site in France.
Trial summary
Interventional study with minimal risks and constraints, prospective, monocentric. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfusion
- What is being tested?
- Jugular ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2018to 23 Aug 2018
- Phase
- Interventional
- 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
Who may be able to join
- Major patient;
- Requiring a transfusion of 2 or more red blood cells in a routine care situation (transfusion programmed in the context of a day hospital or a traditional hospitalization, except in cases of massive bleeding);
- Affiliate or beneficiary of a social protection scheme;
- Having given his written consent.
Who cannot join
- Patient with clinical or biological criteria for admission to intensive care as defined in the 1999 US ICU Practice Guidelines;
- Major persons subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty;
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Place of Jugular Ultrasound in the Evaluation of the Volemia by a Clinician Doctor in Routine Care (JUVIA)
Interventional study with minimal risks and constraints, prospective, monocentric.
Read the detailed description
To appreciate the volemia of a patient is a frequent problem in hospital in various situations: renal insufficiency, dyspnea, dysnatremia, etc. The aging of the population, the chronicity of pathologies, overweight among other causes can make it difficult to assess the volume of the disease by the clinic alone. The consequences of a poor evaluation are delayed management and possible iatrogeny.
New discrimination markers have emerged to help the clinician such as "brain natriuretic peptide (BNP)" in dyspnea, and especially transthoracic echocardiography (TTE) assessing filling pressures with a high potency. discrimination. In current practice the TTE has unequal accessibility, and requires trained practitioners. It is difficult to have an TTE performed for all patients where the question arises.
Just as an assessment of the initial volemia is often necessary, there are few objective monitoring criteria. One can quote the variation of the weight or the evolution of certain biological parameters but none is completely specific.
A new marker has been described for a few years: jugular ultrasound. Better accessibility (requires only a probe of 7-9Hz, possibly 5Hz), it can indeed be performed by any practitioner in less than a minute. The jugular distension is a reflection of cardiac pre-load and can be correctly estimated by ultrasound. It has been shown that cardiac decompensated patients have dilated jugular veins compared to a reference population. A low cohort also demonstrated the presence of jugular ultrasound distension in the absence of clinical distension.
In a US study, 119 patients admitted to the emergency department for dyspnea had a sensitivity of 99% for a specificity of 59% for trans-jugular ultrasound in cardiogenic edema.
However, many applications remain to be explored, and the repeated use of jugular ultrasound in the same patient has never been studied. The accessibility of the measure could make it an excellent monitoring tool.
As a clinical situation, the investigators chose a well standardized and studied situation such as blood transfusion that can bridge the preload measured by invasive measures and measured by jugular ultrasound. This situation is complicated in patients in 1 to 5.7% of the situations of secondary pulmonary overload.
- Conditions
- Transfusion
- Being tested
- Jugular ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jugular ultrasoundOther
Performing a jugular ultrasound by 2 operators before and after transfusion
| Study group | Role | What they receive |
|---|---|---|
| Jugular ultrasound | Other | Not described Receives: Other: Jugular ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the volemia
Variation in height of the area where the right jugular vein collapses in centimeters from the angle of Louis.
Measured: Baseline
Secondary outcomes (4)
Transfusion tolerance
Study of transfusion tolerance (pre- and post-transfusion clinical collection, oral interview on D3 with the patient).
Measured: Day 3
Interobserver variability
Inter-observer variability evaluated by the Intra-class Correlation Coefficient
Measured: Baseline
Interobserver variability
Inter-observer variability evaluated by the Bland and Altman graph.
Measured: Baseline
Semi-quantitative measurement variation in the height of the zone where the right jugular vein colludes
The semi-quantitative variation in height measurement will be evaluated by a Chi² test or an exact Fisher test in two ways: improvement observed or no improvement observed
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start15 May 2018
- Primary completion23 Aug 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TransfusionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JEGO Patrick, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484052
- Sponsor's protocol ID
- 35RC17_8832_JUVIA
- Acronym
- JUVIA
- Status last verified
- May 2023
- First submitted
- 16 Mar 2018
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Henriot B, Scanff A, Sebillot M, Lautredoux F, Jego P. Jugular vein ultrasound for estimating changes in blood volume: a new tool for all physicians. Intern Emerg Med. 2021 Oct;16(7):2005-2007. doi: 10.1007/s11739-021-02792-y. Epub 2021 Jul 1. No abstract available.
PubMed 34196887
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place of Jugular Ultrasound in the Evaluation of the Volemia by a Clinician Doctor in Routine Care (JUVIA)
- ClinicalTrials.gov ID
- NCT03484052
- Acronym / sponsor ID
- JUVIA / 35RC17_8832_JUVIA
- Conditions
- Transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 30 Mar 2018 (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.
Interventional study with minimal risks and constraints, prospective, monocentric.
Detailed description
To appreciate the volemia of a patient is a frequent problem in hospital in various situations: renal insufficiency, dyspnea, dysnatremia, etc. The aging of the population, the chronicity of pathologies, overweight among other causes can make it difficult to assess the volume of the disease by the clinic alone. The consequences of a poor evaluation are delayed management and possible iatrogeny.
New discrimination markers have emerged to help the clinician such as "brain natriuretic peptide (BNP)" in dyspnea, and especially transthoracic echocardiography (TTE) assessing filling pressures with a high potency. discrimination. In current practice the TTE has unequal accessibility, and requires trained practitioners. It is difficult to have an TTE performed for all patients where the question arises.
Just as an assessment of the initial volemia is often necessary, there are few objective monitoring criteria. One can quote the variation of the weight or the evolution of certain biological parameters but none is completely specific.
A new marker has been described for a few years: jugular ultrasound. Better accessibility (requires only a probe of 7-9Hz, possibly 5Hz), it can indeed be performed by any practitioner in less than a minute. The jugular distension is a reflection of cardiac pre-load and can be correctly estimated by ultrasound. It has been shown that cardiac decompensated patients have dilated jugular veins compared to a reference population. A low cohort also demonstrated the presence of jugular ultrasound distension in the absence of clinical distension.
In a US study, 119 patients admitted to the emergency department for dyspnea had a sensitivity of 99% for a specificity of 59% for trans-jugular ultrasound in cardiogenic edema.
However, many applications remain to be explored, and the repeated use of jugular ultrasound in the same patient has never been studied. The accessibility of the measure could make it an excellent monitoring tool.
As a clinical situation, the investigators chose a well standardized and studied situation such as blood transfusion that can bridge the preload measured by invasive measures and measured by jugular ultrasound. This situation is complicated in patients in 1 to 5.7% of the situations of secondary pulmonary overload.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jugular ultrasound | Other | Other: Jugular ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patient;
- Requiring a transfusion of 2 or more red blood cells in a routine care situation (transfusion programmed in the context of a day hospital or a traditional hospitalization, except in cases of massive bleeding);
- Affiliate or beneficiary of a social protection scheme;
- Having given his written consent.
Key exclusion criteria (3 listed)
- Patient with clinical or biological criteria for admission to intensive care as defined in the 1999 US ICU Practice Guidelines;
- Major persons subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty;
- Pregnant or lactating woman
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 |
|---|---|---|
| Jugular ultrasoundPerforming a jugular ultrasound by 2 operators before and after transfusion | Other | Jugular ultrasound |
Primary outcome
Evaluation of the volemia
Time frame: Baseline
Variation in height of the area where the right jugular vein collapses in centimeters from the angle of Louis.
4 secondary outcomes
Transfusion tolerance
Time frame: Day 3
Interobserver variability
Time frame: Baseline
Interobserver variability
Time frame: Baseline
Semi-quantitative measurement variation in the height of the zone where the right jugular vein colludes
Time frame: Baseline
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 23 May 2023.
- Results publication: PubMed 34196887Henriot B, Scanff A, Sebillot M, Lautredoux F, Jego P. Jugular vein ultrasound for estimating changes in blood volume: a new tool for all physicians. Intern Emerg Med. 2021 Oct;16(7):2005-2007. doi: 10.1007/s11739-021-02792-y. Epub 2021 Jul 1. No abstract available.
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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.
JEGO Patrick principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jugular ultrasound in people with Transfusion, run by Rennes University Hospital at 1 site in France.
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 4 inclusion and 3 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 23 May 2023. 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 France. 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?
Evaluation of the volemia (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03484052, which also lists 1 linked publication.
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 23 May 2023.