Cerebral Oximetry for Carotid EEA

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Oxygenation; Regional Anesthesia; NIRS; Carotid Thrombendarterectomy
• Intervention / Treatment: Device: NIRS - Near-infrared spectroscopy

• Study Type: Observational
• Enrollment (Anticipated): 126

Contacts and Locations

• Study Contact: Name: Andreas Koköfer, M.D.; Phone Number: 58664 0043-662 4482; Email: a.kokoefer@salk.at

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Recruiting
    • LKH University Clinic Salzburg
    • Contact: Andreas Koköfer, M.D.; Phone Number: 58664 0043 - 662 4482; Email: a.kokoefer@salk.at

Participation Criteria

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

All patients scheduled for CTEA at the University Hospital Salzburg

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
all patients; 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.	Device: NIRS - Near-infrared spectroscopy; Other Names: FORE-SIGHT™ Monitor (CAS Medical Systems, Branford, Connecticut, USA) and INVOS™ (Somanetics, Troy, Michigan, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic parameters	Blood pressure	During the surgical procedure
Hemodynamic parameters	Peripheral oxygen saturation	During the surgical procedure
Hemodynamic parameters	ECG	During the surgical procedure

Collaborators and Investigators

• Sponsor: Salzburger Landeskliniken
• Investigators: Principal Investigator: Andreas Koköfer, M.D., UK für Anästhesiologie, LKH Salzburg

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 27, 2014
• First Posted (Estimate): July 29, 2014

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CerbralOximetry_01