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Completed

NCT Number: NCT03484052

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

Interventional study with minimal risks and constraints, prospective, monocentric.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, Britain, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jugular ultrasound

Other

Performing a jugular ultrasound by 2 operators before and after transfusion

Primary outcomes

  1. 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.

Secondary outcomes

  1. Transfusion tolerance

    Time frame: Day 3

    Study of transfusion tolerance (pre- and post-transfusion clinical collection, oral interview on D3 with the patient).

  2. Interobserver variability

    Time frame: Baseline

    Inter-observer variability evaluated by the Intra-class Correlation Coefficient

  3. Interobserver variability

    Time frame: Baseline

    Inter-observer variability evaluated by the Bland and Altman graph.

  4. Semi-quantitative measurement variation in the height of the zone where the right jugular vein colludes

    Time frame: Baseline

    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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: JUVIA

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2018
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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