Predicting fluid responsiveness in children on low tidal-volume ventilation
Official title: Fluid-responsiveness in Children Ventilated With LOW Tidal Volume - The FLOW Study.
Run by University Hospital, Bordeaux · NCT07494643 · Data updated 2026-11-12
This project will try whether an ultrasound measurement (ΔVPeak) can predict if mechanically ventilated children on low tidal volumes will benefit from a fluid bolus.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 15 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 6 sites (Amiens and 5 other locations) |
| Status | Recruiting |
| Started | November 10, 2025 |
| Main results expected | November 2027 |
| Study ends | November 2027 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT07494643 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children from birth to 15 years who are in a participating pediatric ICU on mechanical ventilation with low tidal volumes (~6 ml/kg) and for whom the care team plans a 10 ml/kg fluid bolus.
✕Probably not a fit
Children with arrhythmias, on extracorporeal support, with open chest, very high respiratory rates, poor echocardiographic windows, or who are not mechanically ventilated are unlikely to benefit from this test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a diagnostic accuracy study testing whether respiratory variability of peak aortic velocity (ΔVPeak) predicts fluid responsiveness in critically ill children ventilated with protective (low) tidal volumes. Eligible children (0 days to 15 years) receiving mechanical ventilation at about 6 ml/kg and due to receive a 10 ml/kg fluid bolus will have echocardiographic measurements before and after the bolus. Fluid responsiveness is defined as a ≥15% increase in stroke volume measured by echocardiography after volume expansion. Patients with arrhythmia, ECMO, open chest, very high respiratory rates, or poor acoustic windows are excluded and measurements are performed at participating PICUs in France.
Why it matters
Potential benefit: If successful, clinicians could use a quick noninvasive ultrasound test to avoid unnecessary fluid boluses and reduce fluid overload in ventilated children.
How similar studies have gone: ΔVPeak is well validated for predicting fluid responsiveness in children ventilated with tidal volumes ≥8 ml/kg, and limited adult and neonatal data suggest cardiopulmonary interaction tests may work at lower tidal volumes, but this exact setting in children has not been validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
CHU d'Amiens Picardie
Amiens, France Recruiting -
CHU de BORDEAUX
Bordeaux, France Recruiting -
CHU de LIMOGES
Limoges, France Recruiting -
Hôpital Necker-Enfants Malades
Paris, France Recruiting -
Hôpital Robert Debré
Paris, France Recruiting -
CHU de Rouen Normandie
Rouen, France Recruiting
Study contacts
- Study coordinator: Julien GOTCHAC, MD
- Email: julien.gotchac@chu-bordeaux.fr
- Phone: 0556795913
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.