Hemorrhage Clinical Trial
— MOSTCARE-PEDOfficial title:
Effectiveness of the Pressure Recording Analytical Method in Predicting the Fluid Responsiveness in Pediatric Surgical Critical Care Patients
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 10 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Necker-Enfants Malades | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stroke volume variation from Mostcare® | Predictability of stroke volume variation (SVV) from Mostcare® for fluid responsiveness.
Patients are defined as responders if stroke volume obtained using echocardiography increased by =15% after volume expansion. |
5 minutes after infusion of bolus fluid | |
Secondary | Absolute values and variation of cardiac output (CO) and cardiac index (CI) from Mostcare® | Correlation with CO and CI measured by transthoracic cardiac ultrasound before and after volume expansion. | 5 minutes after infusion of bolus fluid | |
Secondary | Absolute values and variation of stroke volume (SV) and indexed stroke volume (SVi) from Mostcare® | Correlation with SV and SVi by transthoracic cardiac ultrasound before and after volume expansion. | 5 minutes after infusion of bolus fluid |
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