Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

Completed

• Conditions: Cardiopulmonary Arrest; Aortic Aneurysm, Thoracic; Aortic Diseases; Coronary Artery Disease

• Registration Number: NCT02876263
• Lead Sponsor: University of Helsinki

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-22
• Last Update Submitted: 2016-08-22
• Study First Posted: 2016-08-23
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurological outcome	Monitoring period from anesthesia induction to 48 hours after end of surgery	Permanent neurological damage or death within monitoring period (up to 48 h after surgery)

Trial Locations

Locations (1)

Helsinki University Central Hospital, Department of Cardiac Surgery; 🇫🇮 Helsinki, Uudenmaan lääni, Finland