Clinical trial NCT02876263: Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta
Official title: Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Arrest
Aortic Aneurysm, Thoracic
Aortic Diseases
Coronary Artery Disease
Keywords: aortic diseases
aortic aneurysm
electroencephalography
Near-Infrared spectroscopy
Transcranial Doppler ultrasonography
Cardiopulmonary arrest
Hypothermia, Induced
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2016-08-23
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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.

Eligibility 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

Primary outcomes:
measure: Neurological outcome
timeFrame: Monitoring period from anesthesia induction to 48 hours after end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Department of Cardiac Surgery
state: Uudenmaan lääni
Study officials:
affiliation: Helsinki University Hospital, Department of Cardiac Surgery
name: Ulla-Stina Salminen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.