Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness

Fluid administration is the first-line treatment in hypovolemic states in critically ill patients. Prediction of fluid responsiveness is possible with echocardiography by assessing the variation of the sub-aortic velocity-time integral (AoVTI) during a passive leg raising test (PLR) or Mini-fluid challenge. However, VTI-Ao measurement is not feasible in all patients due to poor echogenicity. Validation of new fluid-responsiveness indices may facilitate the evaluation in this patient population. Among the available indices, variation of the sub-pulmonary VTI is a potential criterion.

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Key information

Conditions

Fluid Resuscitation Fluid Responsiveness Predictability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de réanimation polyvalente - Hopital Nord, Marseille 15, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient with measurable sub-pulmonary VTI in at least one of the two windows: parasternal short-axis or subcostal.
Patient with measurable sub-aortic VTI in apical 4-chamber view before and after PLR maneuver.
Patient with suspected hypovolemia or whose hemodynamic status justifies vasopressor infusion.

Exclusion criteria

Severe left ventricular dysfunction defined by left ventricular ejection fraction (LVEF) < 30%.
Severe right ventricular dysfunction defined by TAPSE < 12 mm.
Cardiac arrhythmia or atrial fibrillation.
Abdominal compartment syndrome.
Amputation of one or both lower limbs.
Intracranial hypertension.
Pregnant women (ruled out by systematic pregnancy test at ICU admission).
Minors.

Treatment and study plan

Fluid bolus administration

Drug

Fluid infusion of 500 mL of a crystalloïd solution is performed for patients with signs of hypovolemia

Primary outcomes

Fluid responsiveness

Time frame: T0 : baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution

Echocardiographic measurement of subaortic velocity time integral (AoVTI) in apical 5-chambers view is performed before (T0 = Baseline) and within 10 mins (T2) after fluid administration.

An increase of 15% or more of AoVTI after fluid administration of 500mL of a crystalloids solution compared to baseline define fluid responsiveness.
Ability of sub-pulmonary VTI variation to predict fluid responsiveness

Time frame: T0 : Baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution

The sub-pulmonary VTI variation (in %) between T0 and T1 is mesured with echocardiography from a transthoracic view (short axis parasternal and sub costal views depending of patient's echogenicity)

Sub-pulmonary VTI variation ability to detect fluid responsiveness is assessed by constructing ROC curves to detect the best cut-off.

Secondary outcomes

Sub-pulmonary VTI values description

Time frame: T0 : baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution

To describe values of Sub-pulmonary VTI (cm) during the time frame measured with echocardiography in subcostal view and / or in parasternal short axis view depending of patient's echogenicity.

Sponsors and collaborators

Lead sponsor

Hospital Nord

Other

Registry information

Official study title

Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness Prospective Observational Study

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Oct 2, 2025
Registry last updated: Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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