Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations3 sites (Limoges and 2 other locations)
StatusRecruiting
StartedNovember 14, 2024
Main results expectedMay 15, 2026
Study endsMay 15, 2026
Registry record updatedApril 21, 2026
Trial IDNCT06486467 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.