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Completed

NCT Number: NCT02876263

Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

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.

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Key information

Conditions

Cardiopulmonary Arrest Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Arterial Occlusive Diseases Arteriosclerosis Body Temperature Changes Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Arrest Heart Diseases Hypothermia Myocardial Ischemia Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Central Hospital, Department of Cardiac Surgery

Helsinki, Uudenmaan Lääni, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Neurological outcome

    Time frame: Monitoring period from anesthesia induction to 48 hours after end of surgery

    Permanent neurological damage or death within monitoring period (up to 48 h after surgery)

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • GE Healthcare

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2016
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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