NCT07494643

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 0 Days – 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Volume expansion is the cornerstone of acute circulatory failure treatment in children. However, inappropriate administration can lead to fluid overload, which is associated with poor outcome. Thus, the search for indicators to predict fluid responsiveness is a major issue in pediatric intensive care unit. In such an emergency context, this assessment must be as simple and fast as possible, and ideally non-invasive. In children, ΔVPeak is the most used and studied test and has an excellent diagnostic accuracy. Moreover, this echocardiography-based test is noninvasive and easy to perform. Unfortunately, this test is only validated in children ventilated with tidal volume of at least 8ml/kg, a rare situation in practice. However, some recent data in both adults and preterm neonates suggest that fluid responsiveness tests based on cardiopulmonary interactions could be used even in patients on protective ventilation. Yet, to date, the diagnostic accuracy of ΔVPeak has never been investigated in children on protective ventilation (low tidal volume), although it is now the most common ventilation strategy in pediatric intensive care units. Therefore, the investigators hypothesize that ΔVPeak is reliable to predict fluid responsiveness in children mechanically ventilated with 6ml/kg tidal volume. Therefore, the investigatorswill evaluate the diagnostic accuracy of ΔVPeak in critically ill children mechanically ventilated with low tidal volume, and for whom the physician in charge prescribed a 10ml/kg volume expansion to treat circulatory failure. The index test will be ΔVPeak. Fluid responsiveness will be defined as a \> 15% increase in echocardiographically-measured stroke volume between baseline and within one hour after fluid expansion (gold standard test). In this non-interventional multicentric prospective study of diagnostic accuracy, children requiring a 10ml/kg volume expansion will be included. Volume expansion will be delayed for a few minutes (\<3min) in order to complete the baseline echocardiogram with standardized measurements, but no supplemental blood test or invasive parameters will be collected. Another echocardiographic evaluation will be conducted within one hour after volume expansion. Patients will be follow-up until PICU discharge.

Conditions

• Circulatory Failure (Shock)

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2025-11-10
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2026-03-27
• Last updated: 2026-04-07

Locations

6 sites across 1 country: France