Place of Jugular Ultrasound in the Evaluation of the Volemia by a Clinician Doctor in Routine Care (JUVIA)

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.

Study Overview

• Status: Completed
• Conditions: Transfusion
• Intervention / Treatment: Other: Jugular ultrasound

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Britain
    • Rennes, Britain, France, 35033
      • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Jugular ultrasound	Other: Jugular ultrasound; Performing a jugular ultrasound by 2 operators before and after transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the volemia	Variation in height of the area where the right jugular vein collapses in centimeters from the angle of Louis.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion tolerance	Study of transfusion tolerance (pre- and post-transfusion clinical collection, oral interview on D3 with the patient).	Day 3
Interobserver variability	Inter-observer variability evaluated by the Intra-class Correlation Coefficient	Baseline
Interobserver variability	Inter-observer variability evaluated by the Bland and Altman graph.	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	Baseline

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: JEGO Patrick, Rennes University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): August 23, 2018
• Study Completion (Actual): August 23, 2018

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 35RC17_8832_JUVIA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No