ClinConnect ClinConnect Logo
Search / Trial NCT06486467

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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 27, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Velocity Time Integral Echocardiography Artificial Intelligence Minimally Trained Operator Reproducibility Fluid Challenge Fluid Responsiveness

ClinConnect Summary

This clinical trial is studying how effectively a new technology, called UltraSight AI, can help less experienced medical staff measure an important heart function known as the Left Ventricular Outflow Tract (LVOT) Velocity-Time Integral (VTI). This measurement is crucial for understanding how well blood is flowing in critically ill patients, especially those showing signs of low blood flow, like low blood pressure or changes in consciousness. The goal is to see if these minimally trained operators can obtain reliable measurements when guided by the AI, compared to expert doctors' results.

To participate in this study, patients must be at least 18 years old and currently hospitalized in an Intensive Care Unit (ICU) where they need fluid treatment due to signs of low blood flow. Some examples of these signs include a significant drop in blood pressure, skin changes, or decreased urine output. Participants will undergo a measurement process while being monitored closely. It's important to note that patients with certain heart conditions or those in emergency situations may not be eligible for this trial. Overall, this study aims to improve the accuracy of heart function measurements, which could lead to better care for critically ill patients.

Gender

ALL

Eligibility 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.

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Limoges, , France

Paris, , France

Paris, , France

Patients applied

0 patients applied

Trial Officials

Bernard MD Cholley, PhD

Principal Investigator

Assistance Publique - Hôpitaux de Paris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported