Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-11-30

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.

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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.

Conditions

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Cardiopulmonary Arrest Aortic Aneurysm, Thoracic Aortic Diseases Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Elective and emergency surgery for aneurysm or dissections of the ascending aorta, operated under extracorporeal circulation, protective deep therapeutic hypothermia and circulatory arrest.

No interventions assigned to this group

On-pump CABG Group

Elective coronary artery bypass grafting (CABG) for coronary heart disease under extracorporeal circulation

No interventions assigned to this group

OPCAB Group

Elective coronary artery bypass grafting (CABG) for coronary heart disease with a beating heart

No interventions assigned to this group

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