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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic accuracy of ΔVPeak | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiographic | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ROC curve (AUROC, percent) of ΔVPeak to diagnose fluid responsiveness | The primary outcome measure of a diagnostic accuracy study is the discriminative ability of an index test (expressed as an area under the ROC curve) to diagnose a condition (defined by a positive gold-standard reference test). In this study:
| Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| AUROC (percent) of the following index test to diagnose fluid responsiveness | Respiratory variability of peak pulmonary velocity i.e. difference between maximal and minimal peak pulmonary velocity (m/s) during 6 cardiac cycles, divided by mean pulmonary aortic velocity (m/s). Peak pulmonary velocity is measured by transthoracic echocardiography with pulsed-Doppler in the right ventricular outflow tract from parasternal view. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien GOTCHAC, MD | Contact | 0556795913 | +33 | julien.gotchac@chu-bordeaux.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens Picardie | Recruiting | Amiens | France |
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| ID | Term |
|---|---|
| D012769 | Shock |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baseline |
| Influencing factors | AUROC of deltaVPeak to diagnose fluid responsiveness in the following subgroups:
And comparison of thoses AUROC (using a De Long test) | Baseline |
| Poor respiratory tolerance | Association between the binary outcome "poor respiratory tolerance of volume expansion" (composite outcome defined as the presence of at least one of the following conditions at the Time Frame "Hours 4": clinically meaningful oxygenation worsening compared to baseline, measured with oxygen saturation related to oxygen intake (fraction of inspired oxygen, percent); clinically meaningful pulmonary compliance worsening compared to baseline, measured in ml/cmH2O with the ventilator; therapeutic incrementation for acute respiratory distress syndrome such as neuromuscular blockade, prone positioning, inhaled nitric oxid or extracorporeal membrane oxygenation) and the following baseline echocardiographic parameters:
| Baseline , immediately after volume expansion |
| Proportion of patients in each age category, according to fluid responsiveness |
| Baseline |
| Sex, in patients with and without fluid responsiveness |
| Baseline |
| Weight, in patients with and without fluid responsiveness |
| Baseline |
| Volume of fluid expansion in patients with and without fluid responsiveness | Volume of fluid expansion during the last 24 hours before inclusion
| Baseline |
| Heart rate in patients with and without fluid responsiveness |
| Baseline |
| Arterial pressure in patients with and without fluid responsiveness |
| Baseline |
| Urine in patients with and without fluid responsiveness | Urine output
| Baseline, |
| Capillary refill time with and without fluid responsiveness |
| Baseline |
| Mottling, in patients with and without fluid responsiveness |
| Baseline |
| fluid balance in patients with and without fluid responsiveness | Cumulative fluid balance since intensive care admission
| Baseline |
| PELODS2 score in patients with and without fluid responsiveness |
| Baseline |
| Inotropic Score in patients with and without fluid responsiveness |
| Baseline |
| Left ventricular ejection fraction in patients with and without fluid responsiveness |
| Baseline |
| venous pressure in patients with and without fluid responsiveness |
| Baseline |
| Blood lactate in patients with and without fluid responsiveness |
| Baseline |
| Length of mechanical ventilation in patients with and without fluid responsiveness |
| Day 28 |
| length of stay in intensive care in patients with and without fluid responsiveness |
| Day 28 |
| Mortality in patients with and without fluid responsiveness |
| Day 28 |
| CHU de BORDEAUX | Recruiting | Bordeaux | France |
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| CHU de LIMOGES | Recruiting | Limoges | France |
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| Hôpital Necker-Enfants Malades | Recruiting | Paris | France |
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| Hôpital Robert Debré | Recruiting | Paris | France |
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| CHU de Rouen Normandie | Recruiting | Rouen | France |
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