Measuring heart function using AI-guided techniques by minimally trained operators
Official title: Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence (MiniTrained-VTI)
Run by Assistance Publique - Hôpitaux de Paris · NCT06486467 · Data updated 2026-11-12
This study is testing if a new AI tool can help less experienced staff accurately measure heart function in critically ill ICU patients, so they can better manage their fluid needs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 3 sites (Limoges and 2 other locations) |
| Status | Recruiting |
| Started | November 14, 2024 |
| Main results expected | May 15, 2026 |
| Study ends | May 15, 2026 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT06486467 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include ICU patients aged 18 and older who exhibit signs of hypoperfusion and require fluid administration.
✕Probably not a fit
Patients with atrial fibrillation or those under emergency medical assistance may not benefit from this study due to the variability in measurements.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the reliability and reproducibility of Left Ventricular Outflow Tract (LVOT) Velocity-Time Integral (VTI) measurements in critically ill patients. It compares the measurements taken by minimally trained operators using UltraSight AI software to those obtained by expert physicians. The study focuses on patients in the Intensive Care Unit (ICU) who require fluid administration due to signs of tissue hypoperfusion. By leveraging artificial intelligence, the goal is to enhance the accuracy of stroke volume assessments, which are crucial for managing hemodynamic instability.
Why it matters
Potential benefit: If successful, this approach could enable more accurate monitoring of tissue perfusion in critically ill patients, potentially improving patient outcomes.
How similar studies have gone: While the application of AI in medical imaging is a growing field, this specific approach to LVOT VTI measurement by minimally trained operators is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hôpital Lariboisière - APHP
Paris, France Recruiting -
Hôpital européen Georges Pompidou - APHP
Paris, France Recruiting -
CHU de Limoges
Limoges, France Not yet recruiting
Study contacts
- Principal investigator: Bernard MD Cholley, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Bernard Cholley
- Email: bernard.cholley@aphp.fr
- Phone: 0156092515
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.