Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

Coronary Artery Disease Clinical Trial

Official title:

Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876263
• Other study ID #: HUS 133/E6/07
• Status: Completed
• Phase: N/A
• First received: August 16, 2016
• Last updated: August 22, 2016
• Start date: September 2007
• Est. completion date: November 2011

Study information

• Verified date: August 2016
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Diseases
• Cardiopulmonary Arrest
• Coronary Artery Disease
• Coronary Disease
• Heart Arrest
• Myocardial Ischemia

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Department of Cardiac Surgery	Helsinki	Uudenmaan lääni

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	GE Healthcare

Country where clinical trial is conducted

Finland, 

References & Publications (6)

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. Epub 2002 Jan 12. — View 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. — View Citation

Jöbsis FF. Noninvasive, infrared monitoring of cerebral and myocardial oxygen sufficiency and circulatory parameters. Science. 1977 Dec 23;198(4323):1264-7. — View 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. — View 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. — View Citation

Tiainen M, Roine RO, Pettilä 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. Epub 2003 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological outcome	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	No