Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02804-53 | Other Identifier | IDRCB number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients less than 6 months old | Patients less than 6 months old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. |
| |
| Patients between 6 and 12 months old | Patients between 6 and 12 months old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. |
| |
| Patients between 1 and 6 years old | Patients between 1 and 6 years old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. |
| |
| Patients between 6 and 10 years old | Patients between 6 and 10 years old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mostcare® device | Other | The Moscare® system is connected to the patient monitoring devices. Data are collected just before and 5 minutes after the vascular filling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Absolute values and variation of stroke volume (SV) and indexed stroke volume (SVi) from Mostcare® |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients between birth and 10 years of age admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilles Orliaguet, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Estelle Vergnaud, MD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker-Enfants Malades | Paris | 75015 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Transthoracic cardiac ultrasound | Other | Transthoracic cardiac ultrasound before and 3 minutes after the vascular filling. |
|
Correlation with SV and SVi by transthoracic cardiac ultrasound before and after volume expansion. |
| 5 minutes after infusion of bolus fluid |
| ID | Term |
|---|---|
| D020896 | Hypovolemia |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided