Actively Recruiting
Fluid-responsiveness in Children Ventilated With LOW Tidal Volume - The FLOW Study.
Led by University Hospital, Bordeaux · Updated on 2026-04-07
60
Participants Needed
6
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fluid-responsiveness in Children Ventilated With LOW Tidal Volume - The FLOW Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 0 days and 15 years old
- Hospitalized in a pediatric intensive care unit
- Prescription of a 10ml/kg (±20%) fluid expansion by the physician to treat circulatory failure
- Receiving mechanical ventilation
- Tidal volume less than 6ml/kg (±15%)
- Undergoing fluid responsiveness echocardiographic assessment as part of routine care
You will not qualify if you...
- Prematurity with corrected gestational age below 37 weeks
- Presence of arrhythmia
- Hemodynamic instability making delay for measurements unsafe
- Being in prone position
- Impaired echocardiographic acoustic window
- Use of extracorporeal membrane oxygenation (ECMO)
- Respiratory rate greater than 60 cycles per minute (including high frequency oscillation)
- Significant breathing movements or high work of breathing
- Restlessness causing patient-ventilator desynchronization
- Open chest condition
- Cardiogenic pulmonary edema
- Known intracardiac or vascular shunt
- Known significant valvopathy
- Refusal to participate by patient or legal guardian
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
CHU d'Amiens Picardie
Amiens, France
Actively Recruiting
2
CHU de BORDEAUX
Bordeaux, France
Actively Recruiting
3
CHU de LIMOGES
Limoges, France
Actively Recruiting
4
Hôpital Necker-Enfants Malades
Paris, France
Actively Recruiting
5
Hôpital Robert Debré
Paris, France
Actively Recruiting
6
CHU de Rouen Normandie
Rouen, France
Actively Recruiting
Research Team
J
Julien GOTCHAC, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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