- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02876263
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
Status
Completed
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
-
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Uudenmaan lääni
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Helsinki, Uudenmaan lääni, Finland, 00029
- Helsinki University Central Hospital, Department of Cardiac Surgery
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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 |
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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.
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On-pump CABG Group
Elective coronary artery bypass grafting (CABG) for coronary heart disease under extracorporeal circulation
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OPCAB Group
Elective coronary artery bypass grafting (CABG) for coronary heart disease with a beating heart
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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
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Permanent neurological damage or death within monitoring period (up to 48 h after surgery)
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Monitoring period from anesthesia induction to 48 hours after end of surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- Frenzel D, Greim CA, Sommer C, Bauerle K, Roewer N. Is the bispectral index appropriate for monitoring the sedation level of mechanically ventilated surgical ICU patients? Intensive Care Med. 2002 Feb;28(2):178-83. doi: 10.1007/s00134-001-1183-4. Epub 2002 Jan 12.
- Tiainen M, Roine RO, Pettila V, Takkunen O. Serum neuron-specific enolase and S-100B protein in cardiac arrest patients treated with hypothermia. Stroke. 2003 Dec;34(12):2881-6. doi: 10.1161/01.STR.0000103320.90706.35. Epub 2003 Nov 20.
- Simmons LE, Riker RR, Prato BS, Fraser GL. Assessing sedation during intensive care unit mechanical ventilation with the Bispectral Index and the Sedation-Agitation Scale. Crit Care Med. 1999 Aug;27(8):1499-504. doi: 10.1097/00003246-199908000-00016.
- Jobsis FF. Noninvasive, infrared monitoring of cerebral and myocardial oxygen sufficiency and circulatory parameters. Science. 1977 Dec 23;198(4323):1264-7. doi: 10.1126/science.929199.
- Hongo K, Kobayashi S, Okudera H, Hokama M, Nakagawa F. Noninvasive cerebral optical spectroscopy: depth-resolved measurements of cerebral haemodynamics using indocyanine green. Neurol Res. 1995 Apr;17(2):89-93. doi: 10.1080/01616412.1995.11740293.
- Lewis PM, Smielewski P, Rosenfeld JV, Pickard JD, Czosnyka M. Monitoring of the association between cerebral blood flow velocity and intracranial pressure. Acta Neurochir Suppl. 2012;114:147-51. doi: 10.1007/978-3-7091-0956-4_27.
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUS 133/E6/07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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