Cerebral Oximetry for Carotid EEA

• Conditions: Carotid Thrombendarterectomy; NIRS; Cerebral Oxygenation; Regional Anesthesia
• Interventions: Device: NIRS - Near-infrared spectroscopy

• Registration Number: NCT02203370
• Lead Sponsor: Salzburger Landeskliniken

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-07
• Study Start: 2014-07
• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-27
• Study First Posted: 2014-07-29
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20
• Primary Completion: 2015-07
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
all patients	NIRS - Near-infrared spectroscopy	All patients will be measured throughout the procedure with both devices. There no further separation into groups as both sensors can be placed on the same patient.

Primary Outcome Measures

Name	Time	Method
absolute tissue saturation (StO2) measured with(FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA)	During the surgical procedure	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.

Secondary Outcome Measures

Name	Time	Method
NSE	Before and after the surgery	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.
S100B	Before and after the surgery	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.

Trial Locations

Locations (1)

LKH University Clinic Salzburg; 🇦🇹 Salzburg, Austria