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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 2, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a method called the Pressure Recording Analytical Method to see how well it can predict how children in critical care will respond to receiving extra fluids. This is especially important for kids who are undergoing surgery or have experienced severe trauma. The researchers want to find out if the measurements taken using this method can accurately show changes in heart function when the child receives fluids.

To participate in this trial, children aged 0 to 10 years who are intubated (have a breathing tube inserted) and receiving mechanical ventilation may be eligible. They must be in a stable condition after surgery or severe injury, and their medical team must decide they need extra fluids. Parents or guardians will need to agree to their child's participation. If the child joins the study, they will undergo additional monitoring to help the doctors understand how well their bodies are responding to the treatment. This trial is currently recruiting participants, and it aims to gather important information that could improve care for critically ill children in the future.

Gender

ALL

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.