跳至主要内容
临床试验/NCT06486467
NCT06486467招募中不适用

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

Assistance Publique - Hôpitaux de Paris6 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
6
主要终点
Relative difference expressed in percentage of LVOT VTI measurement evaluated by the minimally trained operators as compared with LVOT VTI measurement by experts.

研究概览

简要总结

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.

详细描述

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 measure of LVOT VTI obtained by the minimally trained operators and the experts, the correlation between the measures of the VTI variation (% change following a fluid challenge of 250 mL or a passive leg-raising test) between the minimally-trained operators and those obtained by experts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Minimally-trained operators

Other

Group A: Minimally trained operators for LVOT VTI measurement will be intensive care residents and medical students having done less than 20 transthoracic echocardiography (TTE). All untrained operators will benefit from a standardized preliminary minimal training to teach them how to obtain apical 5-chamber view and acquire LVOT VTI using pulsed-wave Doppler according to the guidelines of the American Society of Echocardiography.

干预措施: Fluid challenge (cristalloids) OR passive leg raising (Other)

Expert operators

Other

Group B: Experts are ICU attending physicians considered experienced and competent in TTE (either board certified or considered as experts locally). Experts will also be trained in using the same ultrasound platform equipped with the Ultrasight AI software. All operators will be trained on the same ultrasound platform: Philips Lumify® equipped with the Ultrasight AI software to optimize the quality of the 5-chamber views.

干预措施: Fluid challenge (cristalloids) OR passive leg raising (Other)

结局指标

主要结局

Relative difference expressed in percentage of LVOT VTI measurement evaluated by the minimally trained operators as compared with LVOT VTI measurement by experts.

时间窗: Less than 60 minutes

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.

次要结局

  • 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.(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.(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.(Less than 60 minutes)
  • Percentage of pairs (minimally-trained/expert) with difference of measurement: o < -14% o [-14%; 14%] o > 14%(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.(Less than 60 minutes)
  • Difference of the absolute value of the measure of LVOT VTI obtained by the minimally trained operators and the experts.(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.(Less than 60 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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