Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence
NCT Number: NCT06486467
Acronym: MiniTrainedVTI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Velocity-time Integral Measurement|Critically Ill Patients|Tissue Hypoperfusion
Interventions: OTHER: Fluid challenge (cristalloids) OR passive leg raising
Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: Philips Healthcare|UltraSight
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: CHU de Limoges, Limoges, 87042, France|Hôpital Lariboisière - APHP, Paris, 75010, France|Hôpital européen Georges Pompidou - APHP, Paris, 75015, France

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.

Primary Outcome Measures: Relative difference expressed in percentage of LVOT VTI measurement evaluated by the minimally trained operators as compared with LVOT VTI measurement by experts., To assess the equivalence of measures of LVOT VTI obtained by minimally trained operators as compared with those obtained by the experts, both guided by artificial intelligence.

Both measures of VTI pre and post-fluid challenge will be considered., Less than 60 minutes
Secondary Outcome Measures: The relative difference expressed in percentage of LVOT VTI measurement, pre-fluid challenge, evaluated by the minimally trained operators as compared with those obtained by experts., To assess the equivalence of the individual measures of LVOT VTI, pre-fluid challenge, obtained by the minimally trained operators as compared with those obtained by the experts, both guided by artificial intelligence., Less than 60 minutes|The relative difference expressed in percentage of LVOT VTI measurement, post-fluid challenge, evaluated by the minimally trained operators as compared with those obtained by experts., To assess the equivalence of the individual measures of LVOT VTI, post-fluid challenge, obtained by the minimally trained operators as compared with those obtained by the experts, both guided by artificial intelligence., Less than 60 minutes|Difference in the VTI variation [i.e.: % change after a fluid challenge of 250 mL, or a passive leg-raising test] obtained by the minimally-trained operators and that obtained by experts., To quantify the reproducibility of LVOT VTI measurements between minimally trained operators and experts., Less than 60 minutes|Correlation of the measure of the VTI variation before and after a fluid challenge of 250 mL or after a passive leg-raising test between the minimally trained operators and the experts., Correlation of the measures of the VTI variation before and after a fluid challenge of 250 mL or after a passive leg-raising test between the minimally-trained operators and the experts will be analyzed using the intraclass correlation coefficient and its associated 95% confidence interval. Pearson and Spearmann correlation coefficients will also be calculated., Less than 60 minutes|Difference of the absolute value of the measure of LVOT VTI obtained by the minimally trained operators and the experts., Agreement of the absolute value of the measure of LVOT VTI obtained by the minimally trained operators and the experts using the Bland and Altman's method (bias ± limits of agreement)., Less than 60 minutes|Concordance in therapeutic decision by the blinded attending physician based on the measure of the VTI variation by the minimally trained operators compared to experts., Concordance in therapeutic decision by blinded attending physician (i.e.: continue or interrupt fluid administration) based on the measure of the VTI variation by the minimally trained operators compared to experts will be analyzed using the sensitivity and specificity as well as the negative and positive predictive values and its associated 95% confidence interval. The reference is the decision based on the value obtained by the expert., Less than 60 minutes|Percentage of pairs (minimally-trained/expert) with difference of measurement: o < -14% o [-14%; 14%] o > 14%, Percentage of pairs minimally trained/expert with difference of measurement will be described with the following thresholds:

* \< -14%
* \[-14%; 14%\]
* \> 14%, Less than 60 minutes