Clinical Trial

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

Study acronym: FLOW
Recruiting
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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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-04-08
Trial Details
NCT Number NCT07494643
Lead Sponsor University Hospital, Bordeaux
Conditions Circulatory Failure (Shock)
Enrollment 60 participants
Start Date 2025-11-10
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-04-07