Hôpital Necker-Enfants Malades
Paris, 75015, France
NCT Number: NCT04186416
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.
Looking for future studies?
Notify MeUp to 10 year
All sexes
Observational
Paris, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Moscare® system is connected to the patient monitoring devices. Data are collected just before and 5 minutes after the vascular filling.
Transthoracic cardiac ultrasound before and 3 minutes after the vascular filling.
Time frame: 5 minutes after infusion of bolus fluid
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.
Time frame: 5 minutes after infusion of bolus fluid
Correlation with CO and CI measured by transthoracic cardiac ultrasound before and after volume expansion.
Time frame: 5 minutes after infusion of bolus fluid
Correlation with SV and SVi by transthoracic cardiac ultrasound before and after volume expansion.
Assistance Publique - Hôpitaux de Paris
Other
Effectiveness of the Pressure Recording Analytical Method in Predicting the Fluid Responsiveness in Pediatric Surgical Critical Care Patients
Acronym: MOSTCARE-PED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01210417
Hemorrhage, Hypovolemia
Milan, Italy
View Trial DetailsNCT01010022
Blood Loss, Surgical, Hemorrhage
Sapporo, Hokkaido, Japan
View Trial DetailsNCT06263075
Bone Diseases, Bone Diseases, Developmental
Bologna, BO, Italy
View Trial DetailsNCT05705115
Fluid Loss, Hemodynamic Instability
Oslo, Norway
View Trial Details