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Fluid-responsiveness in Children Ventilated With LOW Tidal Volume - The FLOW Study.
Sponsor: University Hospital, Bordeaux
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.
Key Details
Gender
All
Age Range
0 Days - 15 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-11-10
Completion Date
2027-11
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (6)
CHU d'Amiens Picardie
Amiens, France
CHU de BORDEAUX
Bordeaux, France
CHU de LIMOGES
Limoges, France
Hôpital Necker-Enfants Malades
Paris, France
Hôpital Robert Debré
Paris, France
CHU de Rouen Normandie
Rouen, France