Using a device to predict fluid needs in critically ill children

Effectiveness of the Pressure Recording Analytical Method in Predicting the Fluid Responsiveness in Pediatric Surgical Critical Care Patients

This study tests a new device to see if it can better predict how much fluid critically ill children need during major surgeries or after severe injuries.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: N/A to 10 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Paris)
• Trial ID: NCT04186416 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness of the Pressure Recording Analytical Method using the Mostcare® device to predict fluid responsiveness in pediatric patients undergoing major surgery or suffering from severe trauma. The study aims to continuously monitor stroke volume and cardiac output, comparing these measurements with traditional transthoracic echocardiography to determine if the new method can accurately predict which patients will benefit from fluid administration. By focusing on children aged 0 to 10 years who are intubated and mechanically ventilated, the study seeks to improve hemodynamic evaluations and fluid management in critical care settings.

Who should consider this trial

Good fit: Ideal candidates are children aged 0 to 10 years who are undergoing major surgery or have severe trauma and require mechanical ventilation.

Not a fit: Patients with cardiac rhythm disorders or those not requiring volume expansion may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate fluid management in critically ill children, potentially improving outcomes and reducing complications from fluid overload.

How similar studies have performed: While predictive tools for fluid responsiveness have been validated in adults, this approach in pediatric patients is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Paris

• Hôpital Necker-Enfants Malades — Paris, France (RECRUITING)

Study contacts

• Principal investigator: Gilles Orliaguet, MD, PhD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Gilles Orliaguet, MD, PhD

Conditions: Hypovolemia, Hemorrhage, Fluid Responsiveness, Volume expansion in children, Mostcare® device, Fluid responsiveness, Stroke volume, Transthoracic cardiac echocardiography