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

NCT06486467 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-21

No results posted yet for this study

Summary

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.

Conditions

  • Velocity-time Integral Measurement
  • Critically Ill Patients
  • Tissue Hypoperfusion

Interventions

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

Sponsors & Collaborators

  • Philips Healthcare

    collaborator INDUSTRY

  • UltraSight

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Bernard MD Cholley, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-14
Primary Completion
2026-05-15
Completion
2026-05-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06486467 on ClinicalTrials.gov