Simplified electrical cardiometry test to predict which critically ill children will respond to fluids
Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children
This project tests whether a quick, noninvasive electrical cardiometry measurement during a brief abdominal compression can see if critically ill children (≤8 years) will benefit from a 10 ml/kg fluid bolus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 42 (estimated) |
| Ages | 0 Days to 8 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 4 sites (Le Plessis-Robinson, France and 3 other locations) |
| Trial ID | NCT07522580 on ClinicalTrials.gov |
What this trial studies
This observational diagnostic accuracy study will test whether changes in stroke volume measured by noninvasive electrical cardiometry during a standardized abdominal compression predict which children will increase stroke volume after a 10 ml/kg fluid bolus. Children ≤8 years in participating pediatric intensive care units who are prescribed a fluid expansion and already monitored with electrical cardiometry will undergo a brief, standardized abdominal compression while continuous cardiometry records stroke volume variation. The cardiometry-derived response will be compared to the reference standard—echocardiographic stroke volume measured before and after the fluid bolus, with fluid responsiveness defined as a ≥15% increase. Diagnostic accuracy metrics (sensitivity, specificity, and predictive values) will be calculated to determine whether the cardiometry maneuver can speed bedside decisions and reduce reliance on operator-dependent echocardiography.
Who should consider this trial
Good fit: Critically ill children aged ≤8 years in a participating PICU who are about to receive a 10 ml/kg fluid bolus and are being monitored with noninvasive electrical cardiometry are ideal candidates.
Not a fit: Children with intra-abdominal hypertension, recent abdominal surgery or painful abdominal palpation, poor echocardiographic windows, extreme prematurity (<37 weeks corrected), or unstable hemodynamics that make testing unsafe may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this could help clinicians quickly and noninvasively identify which children need fluids and avoid harmful fluid overload.
How similar studies have performed: Echocardiographic abdominal compression has shown good accuracy in prior studies, but using electrical cardiometry for this maneuver is relatively new and less validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Le Plessis-Robinson, France and 3 other locations
- Hôpital Marie Lannelongue — Le Plessis-Robinson, France, France (Not_yet_recruiting)
- Hôpital Arnaud de Villeneuve - CHU de Montpellier — Montpellier, France, France (Not_yet_recruiting)
- Hôpital mère-enfant - CHU de Nantes — Nantes, France, France (Not_yet_recruiting)
- Hôpital Cardiologique Haut Lévêque - CHU de Bordeaux — Pessac, France, France (Recruiting)
Study contacts
- Study coordinator: Julien GOTCHAC, MD
- Email: julien.gotchac@chu-bordeaux.fr
- Phone: +33 5 24 54 92 19
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.