Velocity-time Integral MeasurementMiniTrainedVTINCT06486467
Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence VTI
A study testing Fluid challenge (cristalloids) OR passive leg raising in people with Velocity-time Integral Measurement and Critically Ill Patients, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Velocity-time Integral Measurement, Critically Ill Patients, Tissue Hypoperfusion
- What is being tested?
- Fluid challenge (cristalloids) OR passive leg raising
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 14 Nov 2024to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with atrial fibrillation, due to the higher variability in LVOT VTI; Patient on Emergency Medical Assistance; Patient under guardianship, curatorship, deprived of liberty.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
CHU de Limoges
Limoges, 87042
Philippe MD Vignon, PHD, 0555058835, philippe.vignon@unilim.fr
Philippe Vignon, PhD
- Recruiting
Hôpital Lariboisière - APHP
Paris, 75010
Benjamin MD Chousterman, PhD, 0149958512, benjamin.chousterman@aphp.fr
Benjamin Chousterman, PhD
- Recruiting
Hôpital européen Georges Pompidou - APHP
Paris, 75015
Bernard MD Cholley, PhD, 0156092515, bernard.cholley@aphp.fr
Bernard Cholley, PhD
About this study
Official title: Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence (MiniTrained-VTI)
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.
Read the detailed 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 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.
- Being tested
- Fluid challenge (cristalloids) OR passive leg raising
- Keywords
- Velocity-time integral, Echocardiography, Artificial Intelligence, Minimally-trained operator, Reproducibility, Fluid challenge, Fluid responsiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challenge (cristalloids) OR passive leg raisingOther
Also called Volume expansion
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Fluid challenge (cristalloids) OR passive leg raising |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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%
Measured: Less than 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start14 Nov 2024
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Velocity-time Integral MeasurementStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare, UltraSight
- Responsible party
- Sponsor
- Investigators
- Bernard MD Cholley, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486467
- Sponsor's protocol ID
- APHP230510
- Other IDs
- 2022-A02820-43
- Acronym
- MiniTrainedVTI
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Publications
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.
PubMed 25392034Mercado 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.
PubMed 28595621Expert 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.
PubMed 24615559Robba 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.
PubMed 34787687Mor-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.
PubMed 37955139Jozwiak 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.
PubMed 30971307Levy 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.
PubMed 41125264
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence (MiniTrained-VTI)
- ClinicalTrials.gov ID
- NCT06486467
- Acronym / sponsor ID
- MiniTrainedVTI / APHP230510
- Keywords
- Velocity-time integral, Echocardiography, Artificial Intelligence, Minimally-trained operator, Reproducibility, Fluid challenge, Fluid responsiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Philips Healthcare, UltraSight
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally-trained operators | Other | Other: Fluid challenge (cristalloids) OR passive leg raisingGroup 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. |
| Expert operators | Other | Other: Fluid challenge (cristalloids) OR passive leg raisingGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with atrial fibrillation, due to the higher variability in LVOT VTI; Patient on Emergency Medical Assistance; Patient under guardianship, curatorship, deprived of liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid challenge (cristalloids) OR passive leg raisingAlso: Volume expansionPatients 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 | Expert operators, Minimally-trained operators |
Primary outcome
Relative difference expressed in percentage of LVOT VTI measurement evaluated by the minimally trained operators as compared with LVOT VTI measurement by experts.
Time frame: 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.
7 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Less than 60 minutes
Difference of the absolute value of the measure of LVOT VTI obtained by the minimally trained operators and the experts.
Time frame: 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.
Time frame: Less than 60 minutes
Percentage of pairs (minimally-trained/expert) with difference of measurement: o < -14% o [-14%; 14%] o > 14%
Time frame: Less than 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 25392034Cecconi 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.
- Background: PubMed 28595621Mercado 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.
- Background: PubMed 24615559Expert 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.
- Background: PubMed 34787687Robba 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.
- Background: PubMed 37955139Mor-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.
- Background: PubMed 30971307Jozwiak 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.
- Derived from this study: PubMed 41125264Levy 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Related trials for Velocity-time Integral Measurement
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RecruitingObservational study
Assessment of LVOT VTI in Healthy Volunteers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernard MD Cholley, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid challenge (cristalloids) OR passive leg raising in people with Velocity-time Integral Measurement and Critically Ill Patients, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernard Cholley (0156092515, bernard.cholley@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative difference expressed in percentage of LVOT VTI measurement evaluated by the minimally trained operators as compared with LVOT VTI measurement by experts. (time frame: Less than 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06486467, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.