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.