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

NCT06486467 | Recruiting

• 2 other identifiers: APHP2305102022-A02820-43
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Velocity-time Integral Measurement; Critically Ill Patients; Tissue Hypoperfusion

Keywords

Velocity-time integral; Echocardiography; Artificial Intelligence; Minimally-trained operator; Reproducibility; Fluid challenge; Fluid responsiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

• 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

• 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

Study Arms (2)

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.

Other: Fluid challenge (cristalloids) OR passive leg raising

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.

Other: Fluid challenge (cristalloids) OR passive leg raising

Interventions

Fluid challenge (cristalloids) OR passive leg raising OTHER

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

Also known as: Volume expansion

Expert operators; Minimally-trained operators

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Philips Healthcare: collaborator
• UltraSight: collaborator

Study Sites (3)

CHU de Limoges

Limoges, 87042, France

NOT YET RECRUITING

Hôpital Lariboisière - APHP

Paris, 75010, France

RECRUITING

Hôpital européen Georges Pompidou - APHP

Paris, 75015, France

RECRUITING

Related Publications (7)

• 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.

  PMID: 25392034 BACKGROUND

• 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.

  PMID: 28595621 BACKGROUND

• 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.

  PMID: 24615559 BACKGROUND

• 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.

  PMID: 34787687 BACKGROUND

• 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.

  PMID: 37955139 BACKGROUND

• 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.

  PMID: 30971307 BACKGROUND

• 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.

  PMID: 41125264 DERIVED

Study Officials

• Bernard MD Cholley, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernard Cholley

CONTACT

0156092515; bernard.cholley@aphp.fr

Cléo Bourgeois

CONTACT

0156095638; cleo.bourgeois@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR)

Locations

FR (3)