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Recruiting Not applicable NCT06486467

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

No applicable phase (e.g. observational)
Conditions: Velocity-time Integral Measurement Critically Ill Patients Tissue Hypoperfusion

Sponsor: Assistance Publique - Hôpitaux de Paris

trial.available_in: БГ
Overview
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.
Description
The main goal of Intensive Care Unit (ICU) physicians is to ensure cellular oxygenation by maintaining adequate organ perfusion in their patients. Stroke volume is a major determinant of tissue perfusion and therefore a key parameter to monitor in patients with hemodynamic instability. Left Ventricular Outflow Tract (LVOT) Velocity-Time Integral (VTI) measured using pulsed wave Doppler is widely used as an estimation of stroke volume to assess hemodynamic modifications. This value reflects the stroke distance, which varies proportionately to stroke volume in case of hemodynamic variations resulting from therapeutic interventions (fluid administration, vasoactive drugs…) or disease processes. An increase in stroke volume (or LVOT VTI) is expected in response to fluid administration and attests for its efficacy. A lack of increase indicates that the cardiovascular system is no longer fluid-responsive, and that fluid administration is not improving tissue perfusion and creates congestion. Therefore, measuring aortic VTI should be a competence required for every ICU physician. However, international ICU guidelines on echocardiography do not consider LVOT VTI measurement as a basic skill but rather as a competence of advanced operators. More recently, the European Society of Intensive Care Medicine published expert recommendations on echocardiography, setting the evaluation of LVOT VTI as basic skill but with a weak recommendation, lacking published evidence to support this statement. The main difficulty in measuring LVOT VTI is obtaining an adequate apical 5-chamber view. Recently, research in artificial intelligence (AI) applied to medical imaging constituted a breakthrough in the acquisition of images. UltraSight is a company specialized in AI applied to echocardiography. Their software is based on neural network using machine learning to analyse extremely precisely the image obtained by an operator. The software indicates to the operator in real time on-screen how to optimize the image by mobilizing the probe until the desired view is correctly obtained, with the best quality. The main objective of the present study is to characterize and to quantify the reliability and reproducibility of LVOT VTI measurements by comparing the measures obtained by minimally trained operators and experts, using an ultrasound platform equipped with real-time AI-based guidance (UltraSight). If interchangeability of minimally trained operators and expert measurements can be demonstrated, this will constitute a strong basis to upgrade the measurement of LVOT VTI as a basic competence in critical care ultrasound. The secondary objectives are to assess the concordance of therapeutic decisions made by the ICU clinician in charge of the patient (i.e.: continue or interrupt fluid administration) based on the VTI variation obtained by the minimally-trained operator, and that based on the VTI variation obtained by the expert, the agreement of the absolute value of the meas
Who can participate
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.
Interventions
Fluid challenge (cristalloids) OR passive leg raising
OTHER
Locations 3
France (3)
CHU de Limoges
Limoges
NOT_YET_RECRUITING
Hôpital Lariboisière - APHP
Paris
Benjamin MD Chousterman, PhD
Hôpital européen Georges Pompidou - APHP
Paris
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
14.11.2024
Completion date
15.05.2026
Registry ID
NCT06486467
Source
clinicaltrials.gov
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