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

NCT04360304 | Completed

• 2 other identifiers: LOCAL/2019/CR-012019-A02036-51
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Circulatory Failure

Outcome Measures

Primary Outcomes (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.

  DAY 0

Secondary Outcomes (11)

• Correlation between automated and manual method

  DAY 0

• Rate of inappropriate measurement by the software-1

  DAY 0

• Rate of inappropriate measurement by the software-2

  DAY 0

• Rate of inappropriate measurement by the software-3

  DAY 0

• Rate of inappropriate measurement by the software-4

  DAY 0

Study Arms (1)

Study group

EXPERIMENTAL

Device: Echocardiographic exam

Interventions

Echocardiographic exam DEVICE

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 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, Gard, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 39287731 RESULT

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: April 24, 2020
• Study Start: January 29, 2020
• Primary Completion: September 24, 2020
• Study Completion: October 22, 2020
• Last Updated: December 4, 2025

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)