Chu de Nantes
Nantes, France
NCT Number: NCT04295239
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 autoregulation and the occurrence of perioperative encephalopathy is not known. The purpose of this study is to determine whether disturbances in brain autoregulation 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 autoregulation limits and the appearance of brain lesions suggestive of low brain output. Secondary objectives will investigate the association between time spent outside autoregulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria and will study factors predictive of the development of postoperative encephalopathy.
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All sexes
Interventional
Not applicable
Nantes, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pre and Post operative MRI
Time frame: 6 weeks after cardiac surgery
duration of period outside cerebral autoregulation 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.
Time frame: 6 weeks after cardiac surgery
duration of period outside cerebral autoregulation limits, Standardized clinical examination according to Amiel Tison at hospital discharge.
Time frame: day 1 (cardiac surgery)
duration of extra-corporal circulation,
Time frame: day 1 (cardiac surgery)
duration of aortic clamp
Time frame: day 1 (cardiac surgery)
duration of selective cerebral perfusion,
Time frame: day 1 (cardiac surgery)
duration of hypothermia deepness
Time frame: day 1 (cardiac surgery)
duration of critical NIRS
Time frame: day 1 (cardiac surgery)
duration of critical median arterial pression (PAM)
Nantes University Hospital
Other
Acronym: NEMOCARD
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