Fluid-responsiveness in Children Ventilated With LOW Tidal Volume - The FLOW Study.
University Hospital, Bordeaux
60 participants
Nov 10, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- Age between 0 days and 15 years old
- Patient hospitalized in a pediatric intensive care unit.
- Prescription of a 10ml/kg (±20%) fluid expansion by the physician in charge, as a standard care treatment of circulatory failure (precise indication is up to the physician in charge).
- Mechanical ventilation
- Tidal volume < 6ml/kg (±15%)
- Fluid responsiveness echocardiographic assessment as of routine care
Exclusion Criteria14
- Prematurity (corrected gestational age bellow 37 weeks)
- Arythmia
- Hemodynamic instability making dangerous the delay necessary for any measurement.
- Prone position
- Impairment of echocardiographic acoustic window
- Extracorporeal membrane oxygenation
- Respiratory rate (measured) > 60 cycles per minute (including high frequency oscillation)
- Significant breathing movements (high work of breathing, clinically assessed)
- Restlessness with desynchronization patient/ventilator
- Open chest
- Cardiogenic pulmonary oedema
- Known intracardiac or vascular shunt
- Known hemodynamically significant valvopathy
- Opposition to participate expressed by the patient or by a parent or legal guardian
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Interventions
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)
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NCT07494643