Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-8
SponsorUniversity Hospital, Bordeaux
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
patient hospitalised in intensive care or in a continuous monitoring unit
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
validation a test of fluid-responsiveness in critically ill children
Diagnostic testThis test is based on an assessment of the hemodynamic effects of a standardized abdominal compression, using electrical cardiometry.
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Patient in paediatric intensive care unit1 intervention
Trial outcomes
Primary outcomes
1
Area under the ROC curve (AUROC, %) of ΔSV-ACICON to diagnose fluid responsiveness
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
Time frame
between baseline and 1 hourSecondary outcomes
1
AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )
Respiratory variability of peak aortic velocity at baseline (%)
Time frame
between baseline and 1 hour2
AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )
Respiratory variability of inferior vena cava diameter at baseline (%)
Time frame
between baseline and 1 hour3
AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )
Stroke volume respiratory variations at baseline (%), measured with electrical cardiometry
Time frame
between baseline and 1 hour4
AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )
Abdominal compression induced variations in arterial pressure (%)
Time frame
between baseline and 1 hourSponsors and contacts
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Source ClinicalTrials.gov