Cerebral Oximetry for Carotid EEA

NCT ID: NCT02203370

Last Updated: 2015-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Carotid Thrombendarterectomy Cerebral Oxygenation NIRS Regional Anesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

NIRS - Near-infrared spectroscopy

Intervention Type DEVICE

Interventions

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NIRS - Near-infrared spectroscopy

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Salzburger Landeskliniken

OTHER

Sponsor Role lead

Responsible Party

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Andreas Kokoefer

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Koköfer, M.D.

Role: PRINCIPAL_INVESTIGATOR

UK für Anästhesiologie, LKH Salzburg

Locations

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LKH University Clinic Salzburg

Salzburg, Salzburg, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Andreas Koköfer, M.D.

Role: CONTACT

0043-662 4482 ext. 58664

Facility Contacts

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Andreas Koköfer, M.D.

Role: primary

0043 - 662 4482 ext. 58664

Other Identifiers

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CerbralOximetry_01

Identifier Type: -

Identifier Source: org_study_id

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