Actively Recruiting
Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-15
100
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
The Pressure Recording Analytical Method, invasive hemodynamic monitoring, is an uncalibrated pulse contour analysis, installed in the Mostcare® system that allows a continuous estimation of the stroke volume and thus the cardiac output, by the relationship between the area under the curve of the systolic portion of the arterial blood pressure curve and the dynamic impedance of the cardiovascular system. The objectives of the study are to determine if the parameters measured by Mostcare® make it possible to predict the response to volume expansion in pediatric surgical critical care patients, sedated, intubated and ventilated, by comparing the changes in stroke volume, induced by a volume expansion, measured by trans-thoracic echocardiography.
CONDITIONS
Official Title
Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 0 to 10 years old, of both sexes.
- Perioperative period of surgery under general anesthesia requiring admission to surgical resuscitation (before and / or after the surgical procedure).
- Patients admitted for severe trauma.
- Patient installation: supine position.
- Intubation and mechanical ventilation: tidal volume: 7 to 8 ml / kg, Positive expiratory pressure : 3-4 cm H2O, inspiration / expiration: 1 / 1.5 to 1/2; respiratory rate: 1 month up to 2 years = 30 / min; children 2-8 years = 20 / min; children> 8 years = 15 / min.
- Patients with arterial catheters.
- Need for a volume expansion : indication given by the doctor in charge of the patient.
- Non-opposition expressed by the holders of parental authority.
You will not qualify if you...
- Cardiac rhythm disorders (in particular atrial fibrillation, junctional tachycardia, ventricular arrhythmias), with the exception of sinus tachycardia, respiratory variations of heart rate and sporadic atrial / ventricular extrasystoles whom will allow inclusion.
- Cardiopathy: severe systolic dysfunction (shortening fraction <28%, ejection fraction <50%); valvulopathy (significant narrowing or valvular insufficiency); left-right shunt, persistent arterial duct.
- Unstable hemodynamic status related to active bleeding requiring vascular filling > 2 mL / kg / min or requiring vasopressor or inotropic therapy whose dosage had to be changed in the last five minutes.
- Need for mechanical ventilation with a tidal volume> 10 mL / kg or <7 mL / kg.
- Refusal of the patient or the holders of parental authority to exploit the collected data.
- Impossibility to carry out measurements.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Necker-Enfants Malades
Paris, France, 75015
Actively Recruiting
Research Team
G
Gilles Orliaguet, MD, PhD
CONTACT
H
Hélène Morel
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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