Cerebral Oximetry for Carotid EEA

Salzburger Landeskliniken

Status: Unknown

Conditions: Carotid Thrombendarterectomy; Cerebral Oxygenation; NIRS; Regional Anesthesia

Treatments: Device: NIRS - Near-infrared spectroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT02203370

CerbralOximetry_01

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

126 participants in 1 patient group

all patients

Description:

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.

Treatment:

Device: NIRS - Near-infrared spectroscopy