Actively Recruiting

Age: 0 - 10Years
All Genders
ID04186416

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

Age: 0 - 10Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

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

Loading map...

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

Similar Trials

A Phase III, Open Label, Randomized, Controlled Study of VBI...

Septic Shock

Actively Recruiting

6 locations

Acutelines: a Large Biobank Aiming to Improve Early Recognit...

Acute Disease

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here