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

Primary Purpose

Acute Circulatory Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echocardiographic exam
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Circulatory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nîmes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Correlation between automated and manual method
- Strength of the correlation between the automated and manual method, through estimation of correlation coefficient (Pearson or Spearman)
Rate of inappropriate measurement by the software-1
-Number of the event: Impossibility for the device giving a estimation of mean LVOT VTI
Rate of inappropriate measurement by the software-2
-Number of the event: < 3 spectral patterns traced in patients in sinus rhythm
Rate of inappropriate measurement by the software-3
-Number of the event: < 5 spectral patterns traced in patients in Atrial Fibrilation
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
Rate of inappropriate measurement by the software-5
-Number of the event: Mean LVOT VTI obtained thanks to non-consecutive traces
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.
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.
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.
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
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.

Full Information

First Posted
November 15, 2019
Last Updated
December 17, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT04360304
Brief Title
Assessment of Agreement Between Two Measurement Methods of Left Ventricular Outflow Tract (LVOT) Velocity Time Integral (VTI)
Acronym
AUTO-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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
September 24, 2020 (Actual)
Study Completion Date
October 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Circulatory Failure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Echocardiographic exam
Intervention Description
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.
Primary Outcome Measure Information:
Title
VTI measurement concordance
Description
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.
Time Frame
DAY 0
Secondary Outcome Measure Information:
Title
Correlation between automated and manual method
Description
- Strength of the correlation between the automated and manual method, through estimation of correlation coefficient (Pearson or Spearman)
Time Frame
DAY 0
Title
Rate of inappropriate measurement by the software-1
Description
-Number of the event: Impossibility for the device giving a estimation of mean LVOT VTI
Time Frame
DAY 0
Title
Rate of inappropriate measurement by the software-2
Description
-Number of the event: < 3 spectral patterns traced in patients in sinus rhythm
Time Frame
DAY 0
Title
Rate of inappropriate measurement by the software-3
Description
-Number of the event: < 5 spectral patterns traced in patients in Atrial Fibrilation
Time Frame
DAY 0
Title
Rate of inappropriate measurement by the software-4
Description
-Number of the event: One or more automated spectral tracing by the machine, judged as inappropriate by the expert
Time Frame
DAY 0
Title
Rate of inappropriate measurement by the software-5
Description
-Number of the event: Mean LVOT VTI obtained thanks to non-consecutive traces
Time Frame
DAY 0
Title
Best-VTI value concordance
Description
- 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.
Time Frame
DAY 0
Title
variation of VTI after fluid loading concordance
Description
- Agreement between the variation of VTI after fluid loading obtained by automated and manual method, assessed by Lin's coefficient and Bland-Altman plot.
Time Frame
DAY 0
Title
proportion of patients classified as preload-dependant after fluid challenge concordance
Description
- 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.
Time Frame
DAY 0
Title
respiratory variation of inferior vena cava
Description
- Agreement between respiratory variation of inferior vena cava measured by automated and manual method, assessed by Lin's coefficient and Bland-Altman plot
Time Frame
DAY 0
Title
Rate of inappropriate measurement of respiratory variation of inferior vena cava
Description
- Rate of inappropriate measurement of respiratory variation of inferior vena cava by the software of the automated method.
Time Frame
DAY 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU de Nîmes
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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