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| Name | Class |
|---|---|
| Istituto Giannina Gaslini | OTHER |
| Pediatric Intensive Care Unit, Trousseau University Hospital, France | UNKNOWN |
| Pediatric Intensive Care Unit, Necker University Hospital, France | UNKNOWN |
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Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. The first objective is to investigate the association between CA impairments and neurological outcome assessed by the onset of an ANE. The secondary objective is to study the underlying mechanisms influencing CA.
Patients : All children treated by ECMO in the 4 PICUs involved in the study
Measurements : A correlation coefficient between the variations of regional cerebral oxygen saturation (rScO2) as a surrogate of cerebral blood flow and the variations of arterial blood pressure (ABP) is calculated as an index of autoregulation (cerebral oxygenation index (COx), ICM+ software®). CA is monitored either on left (COxl) or both sides. A COx > 0.3 is considered as critical. Neurological outcome is assessed by the onset of an acute neurologic event (ANE) during the ECMO run.
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| Measure | Description | Time Frame |
|---|---|---|
| Association between CA metrics and neurological outcome | Association between the percentage of time spent in critical region of CA and the onset of an acute neurological event (stroke and/or seizures and/or brain death) or not. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of the influence of PCO2 on CA | Association between PCO2 value (mmHg) and COX value | 1 year |
| Analysis of the influence of PCO2 on CA | Influence of ECMO settings on CA |
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Inclusion Criteria :
Exclusion Criteria :
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100 children admitted to the Pediatric Intensive Care Unit (PICU) of Nantes (France), Trousseau (Paris, France), Necker (Paris, France) or Genoa (Italy) and supported by ECMO for hemodynamic or respiratory indication or during cardiac arrest resuscitation will be included in the study.
As ECMO is an emergency procedure, emergency inclusions may be needed. Other observational study may be conducted in parallel in this population.
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas JORAM, MD | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | France | ||||
| AP-HP Trousseau Hospital |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D012770 | Shock, Cardiogenic |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D009203 | Myocardial Infarction |
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| Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK | UNKNOWN |
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| 1 year |
| Paris |
| 75012 |
| France |
| AP-HP Necker Hospital | Paris | 75015 | France |
| Giannina Gaslini Institute (IRCCS) | Genova | 16148 | Italy |
| D017202 |
| Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |