Actively Recruiting
Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Surgical Critical Care Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-15
100
Participants Needed
1
Research Sites
N/A
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
This research focuses on children aged 0 to 10 years who are undergoing major surgery or have experienced severe trauma with bleeding. It evaluates the Pressure Recording Analytical Method using the Mostcare system, an invasive hemodynamic monitoring device that continuously estimates stroke volume and cardiac output. The study aims to determine if Mostcare can predict which pediatric critical care patients will respond to fluid volume expansion by comparing its measurements with changes detected by trans-thoracic echocardiography. Participants are patients admitted to a pediatric surgical ICU who require volume expansion. The study involves monitoring using the Mostcare device connected to patient monitors, collecting data before and five minutes after fluid infusion. Trans-thoracic cardiac ultrasound is also performed before and three minutes after volume expansion. Patients are grouped by age: less than 6 months, 6 to 12 months, 1 to 6 years, and 6 to 10 years. During the study, children are sedated, intubated, and mechanically ventilated in a supine position. Researchers assess stroke volume variation from Mostcare and compare it to echocardiography changes to identify responders to fluid therapy. Additional cardiac output and stroke volume measurements from Mostcare are also recorded. Participation includes continuous monitoring, data collection, and evaluation of heart function parameters, with observations continuing through fluid infusion and shortly after.
CONDITIONS
Brief 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
- Patients admitted for severe trauma
- Patient installed in supine position
- Intubated and mechanically ventilated with specified tidal volume and respiratory rates
- Presence of arterial catheters
- Need for volume expansion as indicated by the doctor
- Non-opposition expressed by the holders of parental authority
You will not qualify if you...
- Cardiac rhythm disorders excluding sinus tachycardia, respiratory heart rate variations, and sporadic extrasystoles
- Severe cardiopathy including systolic dysfunction, significant valvulopathy, left-right shunt, or persistent arterial duct
- Unstable hemodynamic status related to active bleeding requiring high volume filling or recent vasopressor/inotropic dose changes
- Mechanical ventilation with tidal volume less than 7 mL/kg or greater than 10 mL/kg
- Refusal by patient or parental authority to use collected data
- Inability to perform measurements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of ICU stay requiring volume expansion
Participants undergo continuous hemodynamic monitoring using the Mostcare® device and transthoracic cardiac ultrasound before and after volume expansion to assess fluid responsiveness.
1 monitoring session before and after volume expansion
Trial Site Locations
Total: 1 location
1
Hôpital Necker-Enfants Malades
Paris, France, 75015
Actively Recruiting
Research Team
G
Gilles Orliaguet, MD, PhD
H
Hélène Morel
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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