Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence VTI (MiniTrainedVTI)

April 20, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence (MiniTrained-VTI)

Stroke volume is a major determinant of tissue perfusion and therefore a key parameter to monitor in patients with hemodynamic instability and hypoperfusion. Left Ventricular Outflow Tract (LVOT) Velocity-Time Integral (VTI) measured using pulsed wave Doppler is widely used as an estimation of stroke volume and should be a competence required for every Intensive Care Unit (ICU) physician. Recently, research in Artificial Intelligence (AI) applied to medical imaging constituted a breakthrough in the acquisition of images. The goal of the present study is to characterize and quantify the reliability and reproducibility of LVOT VTI measurements by comparing the measures obtained by minimally-trained operators and expert physicians, guided by UltraSight AI software.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main goal of Intensive Care Unit (ICU) physicians is to ensure cellular oxygenation by maintaining adequate organ perfusion in their patients. Stroke volume is a major determinant of tissue perfusion and therefore a key parameter to monitor in patients with hemodynamic instability. Left Ventricular Outflow Tract (LVOT) Velocity-Time Integral (VTI) measured using pulsed wave Doppler is widely used as an estimation of stroke volume to assess hemodynamic modifications. This value reflects the stroke distance, which varies proportionately to stroke volume in case of hemodynamic variations resulting from therapeutic interventions (fluid administration, vasoactive drugs…) or disease processes. An increase in stroke volume (or LVOT VTI) is expected in response to fluid administration and attests for its efficacy. A lack of increase indicates that the cardiovascular system is no longer fluid-responsive, and that fluid administration is not improving tissue perfusion and creates congestion. Therefore, measuring aortic VTI should be a competence required for every ICU physician. However, international ICU guidelines on echocardiography do not consider LVOT VTI measurement as a basic skill but rather as a competence of advanced operators. More recently, the European Society of Intensive Care Medicine published expert recommendations on echocardiography, setting the evaluation of LVOT VTI as basic skill but with a weak recommendation, lacking published evidence to support this statement.

The main difficulty in measuring LVOT VTI is obtaining an adequate apical 5-chamber view.

Recently, research in artificial intelligence (AI) applied to medical imaging constituted a breakthrough in the acquisition of images. UltraSight is a company specialized in AI applied to echocardiography. Their software is based on neural network using machine learning to analyse extremely precisely the image obtained by an operator. The software indicates to the operator in real time on-screen how to optimize the image by mobilizing the probe until the desired view is correctly obtained, with the best quality.

The main objective of the present study is to characterize and to quantify the reliability and reproducibility of LVOT VTI measurements by comparing the measures obtained by minimally trained operators and experts, using an ultrasound platform equipped with real-time AI-based guidance (UltraSight). If interchangeability of minimally trained operators and expert measurements can be demonstrated, this will constitute a strong basis to upgrade the measurement of LVOT VTI as a basic competence in critical care ultrasound. The secondary objectives are to assess the concordance of therapeutic decisions made by the ICU clinician in charge of the patient (i.e.: continue or interrupt fluid administration) based on the VTI variation obtained by the minimally-trained operator, and that based on the VTI variation obtained by the expert, the agreement of the absolute value of the measure of LVOT VTI obtained by the minimally trained operators and the experts, the correlation between the measures of the VTI variation (% change following a fluid challenge of 250 mL or a passive leg-raising test) between the minimally-trained operators and those obtained by experts.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Limoges, France, 87042
        • Not yet recruiting
        • CHU de LImoges
        • Contact:
        • Principal Investigator:
          • Philippe Vignon, PhD
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou - APHP
        • Contact:
        • Principal Investigator:
          • Bernard Cholley, PhD
      • Paris, France, 75010
        • Recruiting
        • Hopital Lariboisiere - APHP
        • Contact:
        • Principal Investigator:
          • Benjamin Chousterman, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

All patients aged 18 and more

Hospitalized in ICU, in whom fluid administration is considered necessary by the clinician in charge, based on the presence of hypoperfusion criterion:

  • >10% decrease in mean arterial pressure with respect to baseline value
  • Skin mottling, oliguria (<0,5 ml/kg/h)
  • change in the level of consciousness
  • hyperlactatemia
  • decrease in central venous oxygen saturation Affiliation to a French social security system (beneficiary or legal) Participant's or next of kin non-opposition or emergency procedure

Exclusion Criteria:

Patients with atrial fibrillation, due to the higher variability in LVOT VTI; Patient on Emergency Medical Assistance; Patient under guardianship, curatorship, deprived of liberty.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Minimally-trained operators
Group A: Minimally trained operators for LVOT VTI measurement will be intensive care residents and medical students having done less than 20 transthoracic echocardiography (TTE). All untrained operators will benefit from a standardized preliminary minimal training to teach them how to obtain apical 5-chamber view and acquire LVOT VTI using pulsed-wave Doppler according to the guidelines of the American Society of Echocardiography.
Other: Fluid challenge (cristalloids) OR passive leg raising

Patients in whom fluid administration is considered necessary, based on hypoperfusion criteria will be included in the trial.

One member of group A and one of group B will proceed independently to evaluate LVOT VTI, guided by the UltraSight AI software to obtain the best 5-chamber view. The measure of LVOT VTI will be calculated as the average of three consecutive cardiac cycles.

The order of acquisition between group A and B will be randomized. Each operator will be blinded to the values obtained by the other.

After baseline LVOT VTI measurement, a 250 mL fluid challenge of crystalloids or a passive leg raising test (non-pharmacological and reversible fluid challenge of roughly 250 mL), depending on the appreciation of the clinician will be performed. Measurements will be repeated immediately after the fluid challenge by the same operators, still blinded to each other, guided by the UltraSight AI software. The order of the 2nd acquisition will be the same as the 1st acquisition

Other Names:
  • Volume expansion
Other: Expert operators
Group B: Experts are ICU attending physicians considered experienced and competent in TTE (either board certified or considered as experts locally). Experts will also be trained in using the same ultrasound platform equipped with the Ultrasight AI software. All operators will be trained on the same ultrasound platform: Philips Lumify® equipped with the Ultrasight AI software to optimize the quality of the 5-chamber views.
Other: Fluid challenge (cristalloids) OR passive leg raising

Patients in whom fluid administration is considered necessary, based on hypoperfusion criteria will be included in the trial.

One member of group A and one of group B will proceed independently to evaluate LVOT VTI, guided by the UltraSight AI software to obtain the best 5-chamber view. The measure of LVOT VTI will be calculated as the average of three consecutive cardiac cycles.

The order of acquisition between group A and B will be randomized. Each operator will be blinded to the values obtained by the other.

After baseline LVOT VTI measurement, a 250 mL fluid challenge of crystalloids or a passive leg raising test (non-pharmacological and reversible fluid challenge of roughly 250 mL), depending on the appreciation of the clinician will be performed. Measurements will be repeated immediately after the fluid challenge by the same operators, still blinded to each other, guided by the UltraSight AI software. The order of the 2nd acquisition will be the same as the 1st acquisition

Other Names:
  • Volume expansion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative difference expressed in percentage of LVOT VTI measurement evaluated by the minimally trained operators as compared with LVOT VTI measurement by experts.
Time Frame: Less than 60 minutes

To assess the equivalence of measures of LVOT VTI obtained by minimally trained operators as compared with those obtained by the experts, both guided by artificial intelligence.

Both measures of VTI pre and post-fluid challenge will be considered.
Less than 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relative difference expressed in percentage of LVOT VTI measurement, pre-fluid challenge, evaluated by the minimally trained operators as compared with those obtained by experts.
Time Frame: Less than 60 minutes
To assess the equivalence of the individual measures of LVOT VTI, pre-fluid challenge, obtained by the minimally trained operators as compared with those obtained by the experts, both guided by artificial intelligence.
Less than 60 minutes
The relative difference expressed in percentage of LVOT VTI measurement, post-fluid challenge, evaluated by the minimally trained operators as compared with those obtained by experts.
Time Frame: Less than 60 minutes
To assess the equivalence of the individual measures of LVOT VTI, post-fluid challenge, obtained by the minimally trained operators as compared with those obtained by the experts, both guided by artificial intelligence.
Less than 60 minutes
Difference in the VTI variation [i.e.: % change after a fluid challenge of 250 mL, or a passive leg-raising test] obtained by the minimally-trained operators and that obtained by experts.
Time Frame: Less than 60 minutes
To quantify the reproducibility of LVOT VTI measurements between minimally trained operators and experts.
Less than 60 minutes
Correlation of the measure of the VTI variation before and after a fluid challenge of 250 mL or after a passive leg-raising test between the minimally trained operators and the experts.
Time Frame: Less than 60 minutes
Correlation of the measures of the VTI variation before and after a fluid challenge of 250 mL or after a passive leg-raising test between the minimally-trained operators and the experts will be analyzed using the intraclass correlation coefficient and its associated 95% confidence interval. Pearson and Spearmann correlation coefficients will also be calculated.
Less than 60 minutes
Difference of the absolute value of the measure of LVOT VTI obtained by the minimally trained operators and the experts.
Time Frame: Less than 60 minutes
Agreement of the absolute value of the measure of LVOT VTI obtained by the minimally trained operators and the experts using the Bland and Altman's method (bias ± limits of agreement).
Less than 60 minutes
Concordance in therapeutic decision by the blinded attending physician based on the measure of the VTI variation by the minimally trained operators compared to experts.
Time Frame: Less than 60 minutes
Concordance in therapeutic decision by blinded attending physician (i.e.: continue or interrupt fluid administration) based on the measure of the VTI variation by the minimally trained operators compared to experts will be analyzed using the sensitivity and specificity as well as the negative and positive predictive values and its associated 95% confidence interval. The reference is the decision based on the value obtained by the expert.
Less than 60 minutes
Percentage of pairs (minimally-trained/expert) with difference of measurement: o < -14% o [-14%; 14%] o > 14%
Time Frame: Less than 60 minutes

Percentage of pairs minimally trained/expert with difference of measurement will be described with the following thresholds:

  • < -14%
  • [-14%; 14%]
  • > 14%
Less than 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Philips Healthcare
UltraSight

Investigators

  • Principal Investigator: Bernard MD Cholley, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2024

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230510
  • 2022-A02820-43 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision.

Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.

Processing of shared data must comply with European General Data Protection Regulation (GDPR)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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