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Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02876263
Enrollment
61
Registered
2016-08-23
Start date
2007-09-30
Completion date
2011-11-30
Last updated
2016-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

aortic diseases, aortic aneurysm, electroencephalography, Near-Infrared spectroscopy, Transcranial Doppler ultrasonography, Cardiopulmonary arrest, Hypothermia, Induced

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.

Interventions

None listed

Sponsors

GE Healthcare
CollaboratorINDUSTRY
University of Helsinki
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neurological outcomeMonitoring period from anesthesia induction to 48 hours after end of surgeryPermanent neurological damage or death within monitoring period (up to 48 h after surgery)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026