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RECRUITING
NCT07494643
NA

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Days - 15 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-11-10

Completion Date

2027-11

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

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.

Locations (6)

CHU d'Amiens Picardie

Amiens, France

CHU de BORDEAUX

Bordeaux, France

CHU de LIMOGES

Limoges, France

Hôpital Necker-Enfants Malades

Paris, France

Hôpital Robert Debré

Paris, France

CHU de Rouen Normandie

Rouen, France