Clinical Trials Directory

Trials / Completed

CompletedNCT02876263

Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

Status
Completed
Phase
Study type
Observational
Enrollment
61 (actual)
Sponsor
University of Helsinki · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2007-09-01
Primary completion
2011-11-01
Completion
2011-11-01
First posted
2016-08-23
Last updated
2016-08-23

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT02876263. Inclusion in this directory is not an endorsement.