Cerebral Oximetry for Carotid EEA

NCT02203370 | Unknown

• 1 other identifier: CerbralOximetry_01
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Thrombendarterectomy; Cerebral Oxygenation; NIRS; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• NSE

  Before and after the surgery

• S100B

  Before and after the surgery

Other Outcomes (3)

• Hemodynamic parameters

  During the surgical procedure

• Hemodynamic parameters

  During the surgical procedure

• Hemodynamic parameters

  During the surgical procedure

Study Arms (1)

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

Interventions

NIRS - Near-infrared spectroscopy DEVICE

Also known as: FORE-SIGHT™ Monitor (CAS Medical Systems, Branford, Connecticut, USA) and INVOS™ (Somanetics, Troy, Michigan, USA)

all patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for CTEA at the University Hospital Salzburg

You may qualify if:

• \- Patients with electively scheduled carotid thrombendarterectomy in regional anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Salzburger Landeskliniken: lead

Study Sites (1)

LKH University Clinic Salzburg

Salzburg, Salzburg, 5020, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

S100B and NSE blood samples taken twice, before and after the surgical procedure

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Andreas Koköfer, M.D.

  UK für Anästhesiologie, LKH Salzburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Koköfer, M.D.

CONTACT

0043-662 4482; a.kokoefer@salk.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 29, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2016
• Last Updated: May 20, 2015

Record last verified: 2014-07

Locations

AU (1)