Measuring heart function using AI-guided techniques by minimally trained operators
Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence (MiniTrained-VTI)
NA · Assistance Publique - Hôpitaux de Paris · NCT06486467
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 3 sites (Limoges and 2 other locations) |
| Trial ID | NCT06486467 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include ICU patients aged 18 and older who exhibit signs of hypoperfusion and require fluid administration.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Limoges and 2 other locations
- CHU de Limoges — Limoges, France (NOT_YET_RECRUITING)
- Hôpital Lariboisière - APHP — Paris, France (RECRUITING)
- Hôpital européen Georges Pompidou - APHP — Paris, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Velocity-time Integral Measurement, Critically Ill Patients, Tissue Hypoperfusion, Velocity-time integral, Echocardiography, Artificial Intelligence, Minimally-trained operator, Reproducibility