Fluid-responsiveness in Children Ventilated With LOW Tidal Volume - The FLOW Study.

Condition(s) studied

Investigational drug(s) / intervention(s)

Echocardiographic: Patients included in this study would have received volume expansion anyway, as the prescription of 10ml/kg volume expansion by the physician in charge is the main inclusion criterion. The purpose of this study is to evaluate the diagnostic accuracy of a fluid responsiveness test. To this end, patients will undergo echocardiographic assessments, which are non-invasive, non-radiative, well tolerated and commonly used in this population as a standard of care in our center. No additional blood test or invasive parameters will be collected be collected.

Study summary

In this study of diagnostic accuracy, the investigators aim to validate a fluid-responsiveness test in critically ill children mechanically ventilated with low tidal volume. This test is the famous respiratory variability of peak aortic velocity (ΔVPeak), which is based on cardiopulmonary interactions but is only validated in mechanically ventilated children with a tidal volume of at least 8ml/kg, which is uncommon nowadays. This would help physicians to identify children ventilated with low tidal volume and suffering from acute circulatory failure that could benefit from a volume expansion, thus avoiding a potentially useless or even dangerous fluid expansion that could lead to fluid overload.

To this end, the diagnostic accuracy of ΔVPeak to predict fluid responsiveness (define as a 15% increase in echocardiographically measured SV after volume expansion) will be measured in mechanically ventilated children with low tidal volume and requiring fluid bolus.

Eligibility

Primary outcome measure(s)

• Area under the ROC curve (AUROC, percent) of ΔVPeak to diagnose fluid responsiveness — Baseline
  The primary outcome measure of a diagnostic accuracy study is the discriminative ability of an index test (expressed as an area under the ROC curve) to diagnose a condition (defined by a positive gold-standard reference test). In this study: * The index test is ΔVPeak at baseline = difference between maximal and minimal peak aortic velocity (m/s) during 5 cardiac cycles, divided by mean peak aortic velocity (m/s). Peak aortic velocity is measured by transthoracic echocardiography with pulsed-Doppler in the left ventricular outflow tract from an apical 5-chambers view. * The condition is "fluid responsiveness" * The gold-standard reference test to diagnose fluid responsiveness is a stroke volume (SV) increase of at least 15% between baseline and after volume expansion: ΔSV-VE \> 15% = ((SV after volume expansion - SV at baseline) / SV at baseline) \> 15%. SV (ml) will be measured by transthoracic echocardiography as the product of left ventricular outflow tract surface (cm², from a par

Trial sites (6)

More University Hospital, Bordeaux trials in France