Carotid ThrombendarterectomyNCT02203370
Cerebral Oximetry for Carotid EEA
An observational study of Carotid Thrombendarterectomy and Cerebral Oxygenation, run by Salzburger Landeskliniken at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Thrombendarterectomy, Cerebral Oxygenation, NIRS
- What is being tested?
- NIRS - Near-infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for CTEA at the University Hospital Salzburg
Who may be able to join
- Patients with electively scheduled carotid thrombendarterectomy in regional anesthesia
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
LKH University Clinic Salzburg
Salzburg, State of Salzburg, 5020
Andreas Koköfer, M.D., 0043 - 662 4482 ext. 58664, a.kokoefer@salk.at
About this study
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.
- Being tested
- NIRS - Near-infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS - Near-infrared spectroscopyDevice
Also called FORE-SIGHT™ Monitor (CAS Medical Systems, Branford, Connecticut, USA) and INVOS™ (Somanetics, Troy, Michigan, USA)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NIRS - Near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the surgical procedure
Secondary outcomes (2)
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.
Measured: 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.
Measured: Before and after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid ThrombendarterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salzburger Landeskliniken
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Kokoefer, Salzburger Landeskliniken
- Investigators
- Andreas Koköfer, M.D., Principal investigator, UK für Anästhesiologie, LKH Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203370
- Sponsor's protocol ID
- CerbralOximetry_01
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oximetry for Carotid EEA
- ClinicalTrials.gov ID
- NCT02203370
- Acronym / sponsor ID
- CerbralOximetry_01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Salzburger LandesklinikenUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | – | Device: NIRS - Near-infrared spectroscopyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for CTEA at the University Hospital Salzburg
Key inclusion criteria (1 listed)
- Patients with electively scheduled carotid thrombendarterectomy in regional anesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS - Near-infrared spectroscopyAlso: FORE-SIGHT™ Monitor (CAS Medical Systems, Branford, Connecticut, USA) and INVOS™ (Somanetics, Troy, Michigan, USA) | Device | all patients |
Primary outcome
absolute tissue saturation (StO2) measured with(FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA)
Time frame: 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.
2 secondary outcomes
NSE
Time frame: Before and after the surgery
S100B
Time frame: Before and after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Koköfer, M.D. principal investigator
UK für Anästhesiologie, LKH Salzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Thrombendarterectomy and Cerebral Oxygenation, run by Salzburger Landeskliniken at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Koköfer, M.D. (0043-662 4482 ext. 58664, a.kokoefer@salk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absolute tissue saturation (StO2) measured with(FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA) (time frame: During the surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.