validation a test of fluid-responsiveness in critically ill children
validation a test of fluid-responsiveness in critically ill children: This test is based on an assessment of the hemodynamic effects of a standardized abdominal compression, using electrical cardiometry.
Study summary
In this study of diagnostic accuracy, the investigators aim to validate a faster, simpler, and noninvasive test of fluid-responsiveness in critically ill children. This test is based on an assessment of the hemodynamic effects of a standardized abdominal compression, using electrical cardiometry. This would help physicians to identify more easily which patient 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 electrical cardiometry-based stroke volume (SV) variation induced by a standardized abdominal compression to predict fluid responsiveness (define as a 15% increase in echocardiographically measured SV after volume expansion) will be measured.
Eligibility
Sex
ALL
Min age
0 Days
Max age
8 Years
Healthy volunteers
No
Inclusion Criteria:
* Age less than or equal to 8 years old
* Hospitalization in a pediatric intensive care unit
* Prescription by the attending physician of a fluid expansion of 10ml/kg
* Use of a non-invasive cardiac output monitoring device (electrical cardiometry) as part of routine care
Exclusion Criteria:
* Patient less than 37 weeks' corrected gestational age
* Hemodynamic instability making the delay necessary for any test dangerous
* Supine position contraindicated or deleterious
* Impairment of echocardiographic acoustic window or restless patient making ultrasonography impossible
* Opposition to participate expressed by the patient or by a parent or legal guardian
* Intra-abdominal hypertension, painful abdominal palpation or abdominal surgery in the last 15 days
Primary outcome measure(s)
Area under the ROC curve (AUROC, %) of ΔSV-ACICON to diagnose fluid responsiveness — between baseline and 1 hour Description: 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:
* The index test is ΔSV-ACICON = difference between stroke volume measured by electrical cardiometry (ml) during a calibrated abdominal compression (30mmHg for 30 seconds) and stroke volume measured by electrical cardiometry at baseline.
* The condition is "fluid responsiveness"
* The gold-standard reference test to diagnose fluid responsiveness is a stroke volume (SV) increase of at least 15% between baseline and after volume expansion: ΔSV-VE \> 15% = ((SV after volume expansion - SV at baseline) / SV at baseline) \> 15%. SV (ml) will be measured by transthoracic echocardiography as the product of left ventricular outflow tract surface (cm², from a parasternal long axis view) and left ventricular outflow tract velocity-time integral
Trial sites (4)
Facility
City
Region
Status
Hôpital Marie Lannelongue
Le Plessis-Robinson
France
Not Yet Recruiting
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier
France
Not Yet Recruiting
Hôpital mère-enfant - CHU de Nantes
Nantes
France
Not Yet Recruiting
Hôpital Cardiologique Haut Lévêque - CHU de Bordeaux
Pessac
France
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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