Predicting fluid responsiveness in children on low tidal-volume ventilation

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 0 Days to 15 Years
• Sex: All
• Sponsor: University Hospital, Bordeaux (Academic / other)
• Locations: 6 sites (Amiens and 5 other locations)
• Trial ID: NCT07494643 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Amiens and 5 other locations

• 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

Conditions Circulatory Failure; echocardiography; fluid responsiveness; goal-directed fluid management; shock; volume expansion