Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

Study Overview
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Brief Summary
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The aim of this prospective, explorative study of noninvasive neuromonitoring was to search potential and practical methods associated with neurological outcome in the perioperative and immediate postoperative setting of surgery of the thoracic aorta. These methods include abbreviated EEG monitoring, near-infrared spectroscopy, transcranial Doppler ultrasound and biochemical markers associated with neuronal damage.

Detailed Description
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For the purpose of this study, 30 patients undergoing aortic surgery via a median sternotomy (n=29; 97%) or left thoracotomy (n=1; 3%) and cardiopulmonary bypass with deep hypothermic cardiac arrest were recruited. All patients were operated under deep hypothermia and circulatory arrest, with optional selective cerebral perfusion during circulatory arrest. Active patient recruitment started from September 2007 and ended in May 2011. All patients were monitored with a bilateral fronto-temporal four channel abbreviated EEG, a bilateral frontal two-channel near-infrared spectroscopy, postoperative transcranial Doppler ultrasound evaluation of median artery circulation and postoperative biochemical neuromarkers. The study montage was set up by a dedicated research nurse, who also performed the transcranial Doppler measurements. The neuromonitoring data were not used at the time to guide therapeutic decisions, with the exception of near-infrared spectroscopy monitoring.

Official Title
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Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

Conditions
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Cardiopulmonary Arrest, Aortic Aneurysm, Thoracic, Aortic Diseases, Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for elective or emergency surgery on the thoracic aorta (study group) or coronary heart disease (control groups) Informed consent from patient or next of kin Exclusion Criteria: Age under 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Elective and emergency surgery for aneurysm or dissections of the ascending aorta, operated under extracorporeal circulation, protective deep therapeutic hypothermia and circulatory arrest. | |
| On-pump CABG Group<br>Elective coronary artery bypass grafting (CABG) for coronary heart disease under extracorporeal circulation | |
| OPCAB Group<br>Elective coronary artery bypass grafting (CABG) for coronary heart disease with a beating heart | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological outcome | Permanent neurological damage or death within monitoring period (up to 48 h after surgery) | Monitoring period from anesthesia induction to 48 hours after end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic diseases, aortic aneurysm, electroencephalography, Near-Infrared spectroscopy, Transcranial Doppler ultrasonography, Cardiopulmonary arrest, Hypothermia, Induced