Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence VTI
NCT ID: NCT06486467
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-11-14
2025-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
TRIPLE
Study Groups
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Minimally-trained operators
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.
Fluid 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
Expert operators
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.
Fluid 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
Interventions
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Fluid 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Philips Healthcare
INDUSTRY
UltraSight
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Bernard MD Cholley, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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CHU de Limoges
Limoges, , France
Hôpital Lariboisière - APHP
Paris, , France
Hôpital européen Georges Pompidou - APHP
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Philippe MD Vignon, PHD
Role: primary
Benjamin MD Chousterman, PhD
Role: primary
Bernard MD Cholley, PhD
Role: primary
References
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Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.
Mercado P, Maizel J, Beyls C, Titeca-Beauport D, Joris M, Kontar L, Riviere A, Bonef O, Soupison T, Tribouilloy C, de Cagny B, Slama M. Transthoracic echocardiography: an accurate and precise method for estimating cardiac output in the critically ill patient. Crit Care. 2017 Jun 9;21(1):136. doi: 10.1186/s13054-017-1737-7.
Expert Round Table on Echocardiography in ICU. International consensus statement on training standards for advanced critical care echocardiography. Intensive Care Med. 2014 May;40(5):654-66. doi: 10.1007/s00134-014-3228-5. Epub 2014 Mar 11. No abstract available.
Robba C, Wong A, Poole D, Al Tayar A, Arntfield RT, Chew MS, Corradi F, Doufle G, Goffi A, Lamperti M, Mayo P, Messina A, Mongodi S, Narasimhan M, Puppo C, Sarwal A, Slama M, Taccone FS, Vignon P, Vieillard-Baron A; European Society of Intensive Care Medicine task force for critical care ultrasonography*. Basic ultrasound head-to-toe skills for intensivists in the general and neuro intensive care unit population: consensus and expert recommendations of the European Society of Intensive Care Medicine. Intensive Care Med. 2021 Dec;47(12):1347-1367. doi: 10.1007/s00134-021-06486-z. Epub 2021 Oct 5.
Mor-Avi V, Khandheria B, Klempfner R, Cotella JI, Moreno M, Ignatowski D, Guile B, Hayes HJ, Hipke K, Kaminski A, Spiegelstein D, Avisar N, Kezurer I, Mazursky A, Handel R, Peleg Y, Avraham S, Ludomirsky A, Lang RM. Real-Time Artificial Intelligence-Based Guidance of Echocardiographic Imaging by Novices: Image Quality and Suitability for Diagnostic Interpretation and Quantitative Analysis. Circ Cardiovasc Imaging. 2023 Nov;16(11):e015569. doi: 10.1161/CIRCIMAGING.123.015569. Epub 2023 Nov 13.
Jozwiak M, Mercado P, Teboul JL, Benmalek A, Gimenez J, Depret F, Richard C, Monnet X. What is the lowest change in cardiac output that transthoracic echocardiography can detect? Crit Care. 2019 Apr 11;23(1):116. doi: 10.1186/s13054-019-2413-x.
Levy N, Meslin S, Barthelemy R, Benremily F, Bourgeois C, Bourzeix P, Chousterman B, Djadi-Prat J, Ep A, Kezar A, Laidet C, Lanoy E, Leopold V, Pereira H, Plateker O, Rivoalen AS, de Roquetaillade C, Vignon P, Bruno J, Cholley B. Reliability of minimally trained operator's left ventricular outflow tract velocity-time integral measurement guided by artificial intelligence: protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Oct 21;15(10):e105624. doi: 10.1136/bmjopen-2025-105624.
Other Identifiers
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2022-A02820-43
Identifier Type: OTHER
Identifier Source: secondary_id
APHP230510
Identifier Type: -
Identifier Source: org_study_id