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Completed

NCT Number: NCT04295239

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

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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Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Nantes

Nantes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Procedure

Pre and Post operative MRI

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.

    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.

Secondary outcomes

  1. describe association between time spent outside autoregulation limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria.

    Time frame: 6 weeks after cardiac surgery

    duration of period outside cerebral autoregulation limits, Standardized clinical examination according to Amiel Tison at hospital discharge.

  2. describe predictive factors of postoperative encephalopathy

    Time frame: day 1 (cardiac surgery)

    duration of extra-corporal circulation,

  3. describe predictive factors of postoperative encephalopathy

    Time frame: day 1 (cardiac surgery)

    duration of aortic clamp

  4. describe predictive factors of postoperative encephalopathy

    Time frame: day 1 (cardiac surgery)

    duration of selective cerebral perfusion,

  5. describe predictive factors of postoperative encephalopathy

    Time frame: day 1 (cardiac surgery)

    duration of hypothermia deepness

  6. describe predictive factors of postoperative encephalopathy

    Time frame: day 1 (cardiac surgery)

    duration of critical NIRS

  7. describe predictive factors of postoperative encephalopathy

    Time frame: day 1 (cardiac surgery)

    duration of critical median arterial pression (PAM)

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: NEMOCARD

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2020
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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