NCT04186416Completed
Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients
Effectiveness of the Pressure Recording Analytical Method in Predicting the Fluid Responsiveness in Pediatric Surgical Critical Care Patients
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Observational
- Enrollment
- 19 (actual)
- First submitted
- 2 Dec 2019
- Start date
- 3 May 2023
- Primary completion date
- 3 Nov 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Stroke
- NCT number
- NCT04186416
What you commit to
- Study type: Observational
- Participants enrolled: 19
- From 3 May 2023 to the primary completion date, 3 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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.
Lab values
- Cardiopathy: severe systolic dysfunction (shortening fraction \<28%, ejection fraction \<50%); valvulopathy (significant narrowing or valvular insufficiency); left-right shunt, persistent arterial duct.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: - to 10 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.