Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence VTI
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
Eligibility
Primary outcome measure(s)
- Relative difference expressed in percentage of LVOT VTI measurement evaluated by the minimally trained operators as compared with LVOT VTI measurement by experts. — 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.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU de Limoges | Limoges | France | Not Yet Recruiting |
| Hôpital Lariboisière - APHP | Paris | France | Recruiting |
| Hôpital européen Georges Pompidou - APHP | Paris | France | Recruiting |
More Assistance Publique - Hôpitaux de Paris trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06486467 on ClinicalTrials.gov ↗ ← All trials in France