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Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02876263
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : August 23, 2016
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Juhani Akseli Stewart, 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.

Condition or disease
Cardiopulmonary Arrest Aortic Aneurysm, Thoracic Aortic Diseases Coronary Artery Disease

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.

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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta
Study Start Date : September 2007
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Group/Cohort
Study group
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
Elective coronary artery bypass grafting (CABG) for coronary heart disease under extracorporeal circulation
OPCAB Group
Elective coronary artery bypass grafting (CABG) for coronary heart disease with a beating heart



Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (18 years or older) scheduled for elective or emergency surgery on the thoracic aorta (study group) or coronary heart disease (control groups)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876263


Locations
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Finland
Helsinki University Central Hospital, Department of Cardiac Surgery
Helsinki, Uudenmaan lääni, Finland, 00029
Sponsors and Collaborators
University of Helsinki
GE Healthcare
Investigators
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Study Director: Ulla-Stina Salminen, MD, PhD Helsinki University Hospital, Department of Cardiac Surgery
Publications:
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Responsible Party: Juhani Akseli Stewart, Doctoral thesis student, University of Helsinki
ClinicalTrials.gov Identifier: NCT02876263    
Other Study ID Numbers: HUS 133/E6/07
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Juhani Akseli Stewart, University of Helsinki:
aortic diseases
aortic aneurysm
electroencephalography
Near-Infrared spectroscopy
Transcranial Doppler ultrasonography
Cardiopulmonary arrest
Hypothermia, Induced
Additional relevant MeSH terms:
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Coronary Artery Disease
Aneurysm
Aortic Aneurysm
Aortic Diseases
Heart Arrest
Aortic Aneurysm, Thoracic
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases