Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

Sponsors

Lead Sponsor: University of Helsinki

Collaborator: GE Healthcare

Source 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.

Overall Status Completed
Start Date September 2007
Completion Date November 2011
Primary Completion Date November 2011
Study Type Observational
Primary Outcome
Measure Time Frame
Neurological outcome Monitoring period from anesthesia induction to 48 hours after end of surgery
Enrollment 61
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ulla-Stina Salminen, MD, PhD Study Director Helsinki University Hospital, Department of Cardiac Surgery
Location
Facility: Helsinki University Central Hospital, Department of Cardiac Surgery
Location Countries

Finland

Verification Date

August 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Helsinki

Investigator Full Name: Juhani Akseli Stewart

Investigator Title: Doctoral thesis student

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Study group

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

Label: On-pump CABG Group

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

Label: OPCAB Group

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

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov