Cerebral Oximetry for Carotid EEA

Regional Anesthesia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02203370
• Other study ID #: CerbralOximetry_01
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2014
• Last updated: May 19, 2015
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2014
• Source: Salzburger Landeskliniken
• Contact: Andreas Koköfer, M.D.
• Phone: 0043-662 4482
• Email: a.kokoefer[@]salk.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

Aim oft he study is to compare two different devices for cerebral oximetry (FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA) in patients undergoing surgical carotid thrombendarterectomy (cTEA) with crossclamped internal carotid artery (ACI). All procedures will be performed in regional anesthesia, therefore the patients will be awake and direct neurological examination during the procedure will be possible, giving information how the drop in cerebral saturation (measured with INVOS and FORESIGHT both on the same patient) correlates with any clinical symptoms.

We expect to see a difference in the total drop and in the delay of the drop of cerebral oxygen saturation, making it possible to detect varieties in specificity and sensitivity of both devices compared to neurologic examination in the awake patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with electively scheduled carotid thrombendarterectomy in regional anesthesia

Exclusion Criteria:

• refusing participation

• age <18 years

• pregnancy

• any contraindication to regional anesthesia or the use of NIRS

• participation in any other study affecting the study protocol

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carotid Thrombendarterectomy
• Cerebral Oxygenation
• NIRS
• Regional Anesthesia

Intervention

Device:
• NIRS - Near-infrared spectroscopy

Locations

Country	Name	City	State
Austria	LKH University Clinic Salzburg	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Salzburger Landeskliniken

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemodynamic parameters	Blood pressure	During the surgical procedure	No
Other	Hemodynamic parameters	Peripheral oxygen saturation	During the surgical procedure	No
Other	Hemodynamic parameters	ECG	During the surgical procedure	No
Primary	absolute tissue saturation (StO2) measured with(FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA)	The drop in StO2 will be compared to the occurrence of any clinical i.e. neurological symptoms during clamping o the carotid artery while cTEA is performed.	During the surgical procedure	No
Secondary	NSE	Biomarker for ischemic brain damage. Serum levels neuron specific enolase (NSE) increases in patients during the acute phase of brain damage. Therefore it is measured to find out whether or not there is correlation to a low oxygen saturation without neurological symptoms during cTEA.	Before and after the surgery	No
Secondary	S100B	Biomarker for ischemic brain damage. Serum levels of S100B increases in patients during the acute phase of brain damage. Therefore it is measured to find out whether or not there is correlation to a low oxygen saturation without neurological symptoms during cTEA.	Before and after the surgery	No