Clinical trial NCT04360304: Assessment of Agreement Between Two Measurement Methods of Left Ventricular Outflow Tract (LVOT) Velocity Time Integral (VTI)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Circulatory Failure
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: VTI measurement concordance
timeFrame: DAY 0
Secondary outcomes:
measure: Correlation between automated and manual method
timeFrame: DAY 0
measure: Rate of inappropriate measurement by the software-1
timeFrame: DAY 0
measure: Rate of inappropriate measurement by the software-2
timeFrame: DAY 0
measure: Rate of inappropriate measurement by the software-3
timeFrame: DAY 0
measure: Rate of inappropriate measurement by the software-4
timeFrame: DAY 0
measure: Rate of inappropriate measurement by the software-5
timeFrame: DAY 0
measure: Best-VTI value concordance
timeFrame: DAY 0
measure: variation of VTI after fluid loading concordance
timeFrame: DAY 0
measure: proportion of patients classified as preload-dependant after fluid challenge concordance
timeFrame: DAY 0
measure: respiratory variation of inferior vena cava
timeFrame: DAY 0
measure: Rate of inappropriate measurement of respiratory variation of inferior vena cava
timeFrame: DAY 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
state: Gard
Study officials:
References: