RecruitingNot ApplicableNCT06486467

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

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

100 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria1

  • Patients with atrial fibrillation, due to the higher variability in LVOT VTI; Patient on Emergency Medical Assistance; Patient under guardianship, curatorship, deprived of liberty.

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Interventions

OTHERFluid challenge (cristalloids) OR passive leg raising

Patients in whom fluid administration is considered necessary, based on hypoperfusion criteria will be included in the trial. One member of group A and one of group B will proceed independently to evaluate LVOT VTI, guided by the UltraSight AI software to obtain the best 5-chamber view. The measure of LVOT VTI will be calculated as the average of three consecutive cardiac cycles. The order of acquisition between group A and B will be randomized. Each operator will be blinded to the values obtained by the other. After baseline LVOT VTI measurement, a 250 mL fluid challenge of crystalloids or a passive leg raising test (non-pharmacological and reversible fluid challenge of roughly 250 mL), depending on the appreciation of the clinician will be performed. Measurements will be repeated immediately after the fluid challenge by the same operators, still blinded to each other, guided by the UltraSight AI software. The order of the 2nd acquisition will be the same as the 1st acquisition


Locations(3)

CHU de Limoges

Limoges, France

Hôpital Lariboisière - APHP

Paris, France

Hôpital européen Georges Pompidou - APHP

Paris, France

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NCT06486467


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