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Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

U

University of Helsinki

Status

Completed

Conditions

Coronary Artery Disease
Cardiopulmonary Arrest
Aortic Aneurysm, Thoracic
Aortic Diseases

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02876263
HUS 133/E6/07

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

61 participants in 3 patient groups

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.
On-pump CABG Group
Description:
Elective coronary artery bypass grafting (CABG) for coronary heart disease under extracorporeal circulation
OPCAB Group
Description:
Elective coronary artery bypass grafting (CABG) for coronary heart disease with a beating heart

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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