NCT06486467 Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence VTI
| NCT ID | NCT06486467 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Velocity-time Integral Measurement |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-14 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-11-14 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Bernard MD Cholley, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06486467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Velocity-time Integral Measurement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06486467 currently recruiting?
Yes, NCT06486467 is actively recruiting participants. Contact the research team at bernard.cholley@aphp.fr for enrollment information.
Where is the NCT06486467 trial being conducted?
This trial is being conducted at Limoges, France, Paris, France, Paris, France.
Who is sponsoring the NCT06486467 clinical trial?
NCT06486467 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Bernard MD Cholley, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 100 participants.