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Acute Circulatory FailureAUTO-VTINCT04360304

Assessment of Agreement Between Two Measurement Methods of Left Ventricular Outflow Tract (LVOT) Velocity Time Integral (VTI)

A study testing Echocardiographic exam in people with Acute Circulatory Failure, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Acute circulatory failure (ACF) is a common cause of admission in intensive care unit (ICU). Echocardiography is a widespread tool nowadays for the initial assessment and the hemodynamic monitoring. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Circulatory Failure
What is being tested?
Echocardiographic exam
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteFrance
Study dates
29 Jan 2020to 22 Oct 2020
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

  • Patient admitted in ICU and presenting an acute circulatory failure, defined by persistent hypotension (SAP < 90mmHg or MAP < 65mmHg) despite fluid resuscitation of 30ml/kg, or the need for vasopressor.
  • Echocardiographic hemodynamic assessment for at least one of the following signs :
  • SAP < 90mmHg; Urine output < 0,5mL/kg/h during more than 2 hours; Blood lactate level > 2mmol/L; Increase of Norepinephrine doses needed
  • The patient or his trusted person / legal representative / member of the family gave his free and informed consent, et have signed the consent form, or patient included in an emergency situation.
  • The patient has to benefit from the French national healthcare insurance.
  • Age ≥ 18 years old.

Who cannot join

  • Participation in another study, or exclusion period from another study assessing the same primary endpoint.
  • Patient placed under judicial protection, or guardianship
  • Patient or his trusted person refuses to sign consent form
  • Pregnant, parturient, or breastfeeding woman
  • Patient with poor echogenic window

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Nîmes

    Nîmes, Gard, 30029

Other trials in France

About this study

Official title: Assessment of Agreement Between Two Measurement Methods of Left Ventricular Outflow Tract (LVOT) Velocity Time Integral (VTI) : Automatic Versus Manual, in Critically Ill Patients in Acute Circulatory Failure

Acute circulatory failure (ACF) is a common cause of admission in intensive care unit (ICU). Echocardiography is a widespread tool nowadays for the initial assessment and the hemodynamic monitoring. An interesting data from this exam is the Left ventricular outflow tract (LVOT) velocity time integral (VTI), reflecting stroke volume, and therefore cardiac output. A new tool for automated recording has been developped on the VENUE GE echograph. This study aims at assessing this automated measurement of LVOT VTI compared with the classic manual method.

Read the detailed description

Acute circulatory failure is a dramatically common issue in critical care, affecting nearly 1/3 of the patients admitted in ICU, and associated with a high morbi-mortality. Echocardiography enables a quick point of care assessment of the hemodynamic status of the patient. One key parameter is stroke volume, which can be estimated by LVOT VTI.

In practice, the guidelines recommend measuring LVOT VTI in a 5 chambers cavity window with pulsed wave doppler, trying to get an angle between aortic flow and the doppler signal as cloth as possible to 0°. Than VTI must be calculated from an average of 3 to 5 cycles in sinus rhythm, or 5 to 10 cycles in arrythmia such as atrial fibrillation. The main issue is that this approach is time consuming and tedious, and most of the practitioners choose to measure only the most representative beat (" Best VTI "), likely to be source of a loss of reproducibility.

In order to make it easier, some companies have developed softwares to help the intensivist. Thereby, General Electric has equiped the VENUE echograph with a system that helps first selecting the proper place for sampling, and then automatically acquire, trace, and calculate the average LVOT VTI based on a 4 seconds sample. Finally, this tool gives a VTI trending when several measures are repeated along the patient' stay.

This program has already been tested on a swine model in hemorrhagic shock with encouraging results (better agreement with cardiac output by thermodilution with the automated method than with the manual one). However, feasibility was only 60%.

This human study aims at assessing the interest of automated LVOT VTI measurement compared to the manual standard one when performing a cardiac echography for hemodynamic assessment of patients hospitalised in ICU. Otherwise, a measure of the " Best-VTI " will be done at the same time in accordance with the current practice, in order to assess this approach.

Finally, when a fluid resuscitation will be indicated, a second exam will be done, and agreement of VTI variation between automated and manual method studied.

Being tested
Echocardiographic exam
Medical subject headings
Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Echocardiographic examDevice

    An echocardiographic exam is realised after inclusion, measuring especially :

    • LVOT VTI
    • Respiratory variation of inferior veina cava diameter For theses two measurements, the manual method is first recorded, and then the automated one is done.

    For patients that need fluid resuscitation of at least 250mL in less than 10minutes (indication at the discretion of the physician in charge of the patient), a second echocardiography is done according to the same protocol described before.

Study groups in NCT04360304
Study groupRoleWhat they receive
Study groupExperimentalNot described
Receives: Device: Echocardiographic exam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VTI measurement concordance

    Agreement between the average LVOT VTI obtained by the manual method, and with the automatic one, estimated through calculation of Lin's coefficient and Bland-Altman plot.

    Measured: DAY 0

Secondary outcomes (11)

  1. Correlation between automated and manual method

    • Strength of the correlation between the automated and manual method, through estimation of correlation coefficient (Pearson or Spearman)

    Measured: DAY 0

  2. Rate of inappropriate measurement by the software-1

    -Number of the event: Impossibility for the device giving a estimation of mean LVOT VTI

    Measured: DAY 0

  3. Rate of inappropriate measurement by the software-2

    -Number of the event: < 3 spectral patterns traced in patients in sinus rhythm

    Measured: DAY 0

  4. Rate of inappropriate measurement by the software-3

    -Number of the event: < 5 spectral patterns traced in patients in Atrial Fibrilation

    Measured: DAY 0

  5. Rate of inappropriate measurement by the software-4

    -Number of the event: One or more automated spectral tracing by the machine, judged as inappropriate by the expert

    Measured: DAY 0

  6. Rate of inappropriate measurement by the software-5

    -Number of the event: Mean LVOT VTI obtained thanks to non-consecutive traces

    Measured: DAY 0

  7. Best-VTI value concordance

    • Agreement between the " Best-VTI " chosen by the expert, the average VTI by manual method, and the automated VTI, assessed by Lin's coefficient and Bland-Altman plot.

    Measured: DAY 0

  8. variation of VTI after fluid loading concordance

    • Agreement between the variation of VTI after fluid loading obtained by automated and manual method, assessed by Lin's coefficient and Bland-Altman plot.

    Measured: DAY 0

  9. proportion of patients classified as preload-dependant after fluid challenge concordance

    • Agreement between the proportion of patients classified as preload-dependant after fluid challenge (LVOT VTI variation ≥ 15%) by automated and manual method, assessed by calculation of Kappa coefficient.

    Measured: DAY 0

  10. respiratory variation of inferior vena cava

    • Agreement between respiratory variation of inferior vena cava measured by automated and manual method, assessed by Lin's coefficient and Bland-Altman plot

    Measured: DAY 0

  11. Rate of inappropriate measurement of respiratory variation of inferior vena cava

    • Rate of inappropriate measurement of respiratory variation of inferior vena cava by the software of the automated method.

    Measured: DAY 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start29 Jan 2020
  3. Primary completion24 Sep 2020
  4. Study completion22 Oct 2020

Resources

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
Model description
This study aims at assessing the interest of automated LVOT VTI measurement compared to the manual standard one when performing a cardiac echography for hemodynamic assessment of patients hospitalised in ICU. Otherwise, a measure of the " Best-VTI " will be done at the same time in accordance with the current practice, in order to assess this approach. Finally, when a fluid resuscitation will be indicated, a second exam will be done, and agreement of VTI variation between automated and manual method studied.
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04360304
Sponsor's protocol ID
LOCAL/2019/CR-01
Other IDs
2019-A02036-51
Acronym
AUTO-VTI
Status last verified
Dec 2020
First submitted
15 Nov 2019
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Louart B, Muller L, Emond B, Boulet N, Roger C. Agreement between manual and automatic ultrasound measurement of the velocity-time integral in the left ventricular outflow tract in intensive care patients: evaluation of the AUTO-VTI(R) tool. J Clin Monit Comput. 2025 Apr;39(2):355-364. doi: 10.1007/s10877-024-01215-5. Epub 2024 Sep 17.

    PubMed 39287731

Questions about this trial

What is this clinical trial studying?

A study testing Echocardiographic exam in people with Acute Circulatory Failure, run by Centre Hospitalier Universitaire de Nīmes 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 6 inclusion and 5 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 4 Dec 2025. 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?

VTI measurement concordance (time frame: DAY 0). 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 NCT04360304, 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 4 Dec 2025.

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