Actively Recruiting
Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children
Led by University Hospital, Bordeaux · Updated on 2026-04-13
42
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a faster, simpler, and noninvasive method to assess fluid responsiveness in critically ill children with circulatory failure. The study aims to validate a test based on the effects of a standardized abdominal compression measured by electrical cardiometry, to help doctors identify which patients might benefit from fluid expansion and avoid harmful fluid overload. This observational, multi-center study focuses on children prescribed a 10 ml/kg volume expansion for circulatory failure in pediatric intensive care units. The study involves performing a standardized abdominal compression maneuver using a sphygmomanometer inflated with 80 ml of air, applying gentle pressure on the patient's abdomen. Stroke volume variation induced by this maneuver is measured continuously with electrical cardiometry, a noninvasive cardiac output monitor. Echocardiography assessments are conducted before and within one hour after fluid expansion to measure stroke volume changes as the gold standard for fluid responsiveness. No additional blood tests or invasive procedures are performed. Participants will undergo echocardiographic and electrical cardiometry evaluations around the time of their prescribed fluid expansion, with monitoring continuing until discharge from the pediatric intensive care unit or up to 28 days. Researchers will analyze the diagnostic accuracy of the abdominal compression test in predicting a 15% or greater increase in stroke volume after fluid expansion. The main outcome measure is the area under the ROC curve for stroke volume variation induced by abdominal compression compared to echocardiographic results.
CONDITIONS
Brief Title
Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 minutes before volume expansion
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Less than 3 minutes
Participants undergo echocardiographic assessments and a standardized abdominal compression maneuver using electrical cardiometry to evaluate fluid responsiveness before volume expansion.
1 evaluation visit (in-person)
Duration - Within 1 hour after volume expansion
Participants receive a 10 ml/kg volume expansion as prescribed by their physician. A follow-up echocardiographic assessment is conducted within one hour after volume expansion to assess response to treatment.
1 follow-up visit (in-person)
Duration - Up to 28 days
Participants are followed until discharge from the pediatric intensive care unit, up to a maximum of 28 days, to observe clinical outcomes.
Ongoing monitoring until discharge
Trial Site Locations
Total: 4 locations
1
Hôpital Marie Lannelongue
Le Plessis-Robinson, France, France, 92350
Not Yet Recruiting
2
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, France, France, 34295
Not Yet Recruiting
3
Hôpital mère-enfant - CHU de Nantes
Nantes, France, France, 44093
Not Yet Recruiting
4
Hôpital Cardiologique Haut Lévêque - CHU de Bordeaux
Pessac, France, France, 33600
Actively Recruiting
Research Team
J
Julien GOTCHAC, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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