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

NCT04295239 | Completed

• 1 other identifier: RC19_0413
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease in Children; Extracorporeal Circulation; Complications

Outcome Measures

Primary Outcomes (1)

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

  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.

  6 weeks after cardiac surgery

Secondary Outcomes (7)

• 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

• describe predictive factors of postoperative encephalopathy

  day 1 (cardiac surgery)

• describe predictive factors of postoperative encephalopathy

  day 1 (cardiac surgery)

• describe predictive factors of postoperative encephalopathy

  day 1 (cardiac surgery)

• describe predictive factors of postoperative encephalopathy

  day 1 (cardiac surgery)

Study Arms (1)

MRI

EXPERIMENTAL

Pre-operative AND post-operative MRI

Procedure: MRI

Interventions

MRI PROCEDURE

Pre and Post operative MRI

MRI

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Chu de Nantes

Nantes, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, prospective and pilot study

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 4, 2020
• Study Start: March 10, 2020
• Primary Completion: February 19, 2022
• Study Completion: February 19, 2022
• Last Updated: July 29, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)