Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

August 22, 2016 updated by: Juhani Akseli Stewart, University of Helsinki
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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Uudenmaan lääni
      • Helsinki, Uudenmaan lääni, Finland, 00029
        • Helsinki University Central Hospital, Department of Cardiac Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Monitoring period from anesthesia induction to 48 hours after end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Ulla-Stina Salminen, MD, PhD, Helsinki University Hospital, Department of Cardiac Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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