NCT04186416

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Children undergoing major surgery or severe trauma with bleeding require regular hemodynamic evaluation, including cardiac output measurement, to maintain adequate organ perfusion. In fact, administration of fluid to improve cardiac output is the mainstay of hemodynamic resuscitation. However, not all patients respond to fluid therapy, and excessive fluid administration is harmful. Therefore, the vascular filling strategy requires a thorough hemodynamic evaluation. Many predictive tools for fluid responsiveness have been validated in adults, and are based on heart-lung interaction in ventilated patients. Up to now, respiratory variation in aortic blood flow peak velocity, measured by transthoracic or transoesophageal cardiac echocardiography, is the only variable shown to effectively predict fluid responsiveness in children. However, the use of these methods does not allow continuous monitoring (trans-thoracic echocardiography) or is not easily achievable in current practice (trans-esophageal echocardiography). In addition, these monitoring tools require learning and inter- and intra-individual variability is not negligible, ranging from 1% to 20%. 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 of 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 goal of this study is to assess the ability of dynamic cardiovascular variables measured using Mostcare® to predict fluid responsiveness in pediatric surgical critical care patients, sedated, intubated and ventilated, in prone position, by comparing the changes in stroke volume (SV), induced by a volume expansion (VE), measured by trans-thoracic echocardiography. For the purpose of the study, responders (Rs) to VE are patients showing an increase in SV measured using transthoracic echocardiography of at least 15% after VE.

Conditions

• Hypovolemia
• Hemorrhage
• Fluid Responsiveness

Interventions

Type	Name	Description
OTHER	Mostcare® device	The Moscare® system is connected to the patient monitoring devices. Data are collected just before and 5 minutes after the vascular filling.
OTHER	Transthoracic cardiac ultrasound	Transthoracic cardiac ultrasound before and 3 minutes after the vascular filling.

Timeline

• Start date: 2023-05-03
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2019-12-04
• Last updated: 2025-09-15

Locations

1 site across 1 country: France