Non-invasive Monitoring of Cerebral Autoregulation in Perioperative Neonatal Cardiac Surgery

Not Applicable

Completed

• Conditions: Congenital Heart Disease in Children; Extracorporeal Circulation; Complications
• Interventions: Procedure: MRI

• Registration Number: NCT04295239
• Lead Sponsor: Nantes University Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Study Start: 2020-03-10
• Primary Completion: 2022-02-19
• Study Completion: 2022-02-19
• Status Verified: 2022-03
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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
• Preoperative extracorporeal assistance
• Preoperative intubation
• Preoperative administration of inotropes
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI	MRI	Pre-operative AND post-operative MRI

Primary Outcome Measures

Name	Time	Method
determine the association between time spent outside individually determined cerebral autoregulation limits and the development of brain lesions suggestive of low brain output.	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.

Secondary Outcome Measures

Name	Time	Method
describe predictive factors of postoperative encephalopathy	day 1 (cardiac surgery)	duration of critical median arterial pression (PAM)
describe association between time spent outside autoregulation limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria.	6 weeks after cardiac surgery	duration of period outside cerebral autoregulation limits, Standardized clinical examination according to Amiel Tison at hospital discharge.

Trial Locations

Locations (1)

Chu de Nantes; 🇫🇷 Nantes, France