NEMOCARD: Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery
Study Details
Study Description
Brief Summary
Cardiac surgery under extracorporeal circulation (ECC) in newborns with congenital heart disease causes significant morbidity and mortality. The perioperative period is a period of major vulnerability implicated in the appearance of these sequelae, and it is therefore essential to monitor brain function during ECC. The quality of cerebral oxygenation in the perioperative period is routinely monitored non-invasively by infra-red spectroscopy, which makes it possible to estimate cerebral tissue oximetry from a surface electrode (NIRS). The association between time spent outside the limits of cerebral self-regulation and the occurrence of perioperative encephalopathy is not known. The purpose of this study is to determine whether disturbances in brain self-regulation during the operative period are associated with the occurrence of postoperative encephalopathy in children operated on for congenital heart disease in the neonatal period. The main objective of the research is to determine the association between time spent outside individually determined cerebral self-regulation limits and the appearance of brain lesions suggestive of low brain output. Secondary objectives will investigate the association between time spent outside self-regulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria and will study factors predictive of the development of postoperative encephalopathy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MRI Pre-operative AND post-operative MRI |
Procedure: MRI
Pre and Post operative MRI
|
Outcome Measures
Primary Outcome Measures
- determine the association between time spent outside individually determined cerebral self-regulatory limits and the development of brain lesions suggestive of low brain output. [6 weeks after cardiac surgery]
duration of period outside cerebral self-regulatory limits, Number, size and extent of new lesions on post-operative MRI. Patients will be classified into 2 categories according to whether or not there are new lesions on MRI. The lesions retained will be infarcts, white matter lesions and intraparenchymal hemorrhages, classified according to the Magnetic Resonance Imaging Abnormality Scoring System.
Secondary Outcome Measures
- describe association between time spent outside self-regulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria. [6 weeks after cardiac surgery]
duration of period outside cerebral self-regulatory limits, Standardized clinical examination according to Amiel Tison at hospital discharge.
- describe predictive factors of postoperative encephalopathy [day 1 (cardiac surgery)]
duration of extra-corporal circulation,
- describe predictive factors of postoperative encephalopathy [day 1 (cardiac surgery)]
duration of aortic clamp
- describe predictive factors of postoperative encephalopathy [day 1 (cardiac surgery)]
duration of selective cerebral perfusion,
- describe predictive factors of postoperative encephalopathy [day 1 (cardiac surgery)]
duration of hypothermia deepness
- describe predictive factors of postoperative encephalopathy [day 1 (cardiac surgery)]
duration of critical NIRS
- describe predictive factors of postoperative encephalopathy [day 1 (cardiac surgery)]
duration of critical median arterial pression (PAM)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Any newborn (0-28 days) with congenital heart disease, hospitalized in the preoperative period at the Nantes University Hospital, for whom a decision is made to perform an operation under extracorporeal circulation, suitable to be transported for an MRI without risk, advice taken from the treating team.
Exclusion Criteria:
-
emergency cardiac surgery
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Preoperative extracorporeal assistance
-
Preoperative intubation
-
Preoperative administration of inotropes
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Pre-operative instability contra-indicating pre-operative MRI
-
Dependence on a pace maker contra-indicating MRI Imaging.
-
Parental consent refusal
-
Non-affiliation to a health security insurance
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu de Nantes | Nantes | France |
Sponsors and Collaborators
- Nantes University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC19_0413