NCT04186416 Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients
| NCT ID | NCT04186416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Hypovolemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-05-03 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-05-03 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Gilles Orliaguet, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04186416 clinical trial?
This trial is open to participants of all sexes, up to 10 Years, studying Hypovolemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04186416 currently recruiting?
Yes, NCT04186416 is actively recruiting participants. Contact the research team at gilles.orliaguet@aphp.fr for enrollment information.
Where is the NCT04186416 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04186416 clinical trial?
NCT04186416 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Gilles Orliaguet, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 100 participants.