Cerebral Oxygen Saturation,MCA Velocity,Intraoperative Neurological Symptoms During Carotid EndarterectomyNCT02665104
Middle Cerebral Artery Velocity and Oxygen Saturation of the Brain During Carotid Endarterectomy
An observational study of Cerebral Oxygen Saturation,MCA Velocity,Intraoperative Neurological Symptoms During Carotid Endarterectomy, run by University of Debrecen at 2 sites in Hungary.
Trial summary
The primary endpoint of our study is to determine whether neurological symptoms (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive regarding the symptoms? Secondary endpoint: the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Oxygen Saturation,MCA Velocity,Intraoperative Neurological Symptoms During Carotid Endarterectomy
- What is being tested?
- transcranial Doppler (TCD) and INVOS monitor
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesHungary
- Study dates
- Apr 2015to Apr 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 100 patients awaiting carotid artery endarterectomy carried out in regional anesthesia. * Age: patients over 18 years. * Gender: both female and male patients are included in the study.
Who may be able to join
- 100 patients awaiting carotid artery endarterectomy carried out in regional anesthesia.
- Age: patients over 18 years.
- Gender: both female and male patients are included in the study.
- Medical equipment: venous catheter, arterial catheter for invasive blood pressure monitoring.
- Bilateral continuous measurement of the middle cerebral arteries with Transcranial Doppler.
- Bilateral continuous measurement of the cerebral saturation with INVOS monitor.
Who cannot join
- Allergy to ropivacaine, bupivacaine.
- Patients who does not consent to the awake surgery or does not sign the informed consent of the study.
- If the patient is either psychologically or neurologically unsuitable for the awake surgery.
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites, 2 recruiting
- Recruiting
University of Debrecen
Debrecen, Hajdú-Bihar, 4032
Béla Fülesdi, MD PhD DSci, 00 36 52 255 347
Zoltán Gyöngyösi, md, 00 36 52 255 347
- Enrolling by invitation
University of Debrecen
Debrecen, 4032
About this study
Official title: Investigation of Blood Flow Velocity in the MCA and Oxygen Saturation of the Brain During Carotid Endarterectomy in Local Anesthesia in Patients With and Without Neurological Symptoms Using Transcranial Doppler (TCD) and INVOS Monitor
The primary endpoint of our study is to determine whether neurological symptoms (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters after the internal carotid artery is clamped, and if there is any difference between the operated and non-operated sides?
Read the detailed description
Investigation of blood flow velocity in the middle cerebral artery and oxygen saturation of the brain bilaterally during carotid endarterectomy carried out in local anesthesia in patients with and without neurological symptoms using transcranial Doppler (TCD) and INVOS monitor.
Zoltán Gyöngyösi Study protocol
The primary endpoint of our study is to determine whether neurological symptoms (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters after the internal carotid artery is clamped, and if there is any difference between the operated and non-operated sides?
Patients and Methods
Outpatient examination, preparation and anesthesia of the patients:
- ECG test
- Echocardiography, if it is necessary due to the cardial status of the patient.
- Indication of surgical intervention provided by the cerebrovascular outpatient clinic, with attached carotid ultrasound and angiography results.
Surgical anesthesia:
- Superficial and deep cervical block with 3.75% ropivacaine (50ml ropivacaine 3.75%) (incase of allergy bupivacaine should be used)
- Securing venous catheter, infusion of Lactated-Ringer or Voluven solution.
- In case of pain topical administration of Lidocaine by the surgeon, intravenous administration of 25-50ug Fentanyl or 1 vial of Algopyrin.
Intraoperative measurements:
- Bilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention.
- Recording mean arterial pressure with each TCD measurement.
- Recording cerebral saturation (INVOS) with each TCD measurement.
- Recording any anti-hypertensive therapy in the postoperative phase.
- Recording heart rate.
- Recording arterial oxygen saturation.
- Recording the patients' neurological status with each TCD measurement and continuous neurological monitoring while the internal carotid artery is clamped.
- Being tested
- transcranial Doppler (TCD) and INVOS monitor
- Keywords
- Cerebral oxygen saturation, TCD, NIRS, Carotid endarterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Doppler (TCD) and INVOS monitorDevice
Bilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| patients without neurological symptoms | carotid endarterectomy patients who dont'have any neurological symptoms after carotid clamping Receives: Device: transcranial Doppler (TCD) and INVOS monitor | |
| patients with neurological symptoms | carotid endarterectomy patients who have new neurological symptoms after carotid clamping Receives: Device: transcranial Doppler (TCD) and INVOS monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms
(aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms
Recording mean arterial flow velocity with each TCD measurement.
Measured: 15 month
to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms
Recording cerebral saturation (INVOS) with each measurement.
Measured: 15 month
Secondary outcomes (1)
the degree of change in the measured parameters during clamp and declamp after the internal carotid artery is clamped, if there is any difference between the operated and non-operated sides?
Recording mean arterial pressure with each TCD measurement. Recording cerebral saturation (INVOS) with each measurement.
Measured: 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral Oxygen Saturation,MCA Velocity,Intraoperative Neurological Symptoms During Carotid EndarterectomyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Debrecen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamas Vegh, MD, University of Debrecen
- Investigators
- Béla Fülesdi, MD,PhD,DSci, Principal investigator, Hungary University of Debrecen Debrecen, Hungary, 4032
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665104
- Sponsor's protocol ID
- DE RKEB/IKEB:4364/2015
- Other IDs
- 094579/2015/OTIG
- Status last verified
- Mar 2017
- First submitted
- 13 Jan 2016
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Williams IM, Mead G, Picton AJ, Farrell A, Mortimer AJ, McCollum CN. The influence of contralateral carotid stenosis and occlusion on cerebral oxygen saturation during carotid artery surgery. Eur J Vasc Endovasc Surg. 1995 Aug;10(2):198-206. doi: 10.1016/s1078-5884(05)80112-1.
PubMed 7655972Pennekamp CW, Immink RV, den Ruijter HM, Kappelle LJ, Bots ML, Buhre WF, Moll FL, de Borst GJ. Near-infrared spectroscopy to indicate selective shunt use during carotid endarterectomy. Eur J Vasc Endovasc Surg. 2013 Oct;46(4):397-403. doi: 10.1016/j.ejvs.2013.07.007. Epub 2013 Aug 21.
PubMed 23973277
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Blood Flow Velocity in the MCA and Oxygen Saturation of the Brain During Carotid Endarterectomy in Local Anesthesia in Patients With and Without Neurological Symptoms Using Transcranial Doppler (TCD) and INVOS Monitor
- ClinicalTrials.gov ID
- NCT02665104
- Acronym / sponsor ID
- DE RKEB/IKEB:4364/2015
- Keywords
- Cerebral oxygen saturation, TCD, NIRS, Carotid endarterectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of DebrecenUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 27 Jan 2016 (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.
The primary endpoint of our study is to determine whether neurological symptoms (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters after the internal carotid artery is clamped, and if there is any difference between the operated and non-operated sides?
Detailed description
Investigation of blood flow velocity in the middle cerebral artery and oxygen saturation of the brain bilaterally during carotid endarterectomy carried out in local anesthesia in patients with and without neurological symptoms using transcranial Doppler (TCD) and INVOS monitor.
Zoltán Gyöngyösi Study protocol
The primary endpoint of our study is to determine whether neurological symptoms (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters after the internal carotid artery is clamped, and if there is any difference between the operated and non-operated sides?
Patients and Methods
Outpatient examination, preparation and anesthesia of the patients:
- ECG test
- Echocardiography, if it is necessary due to the cardial status of the patient.
- Indication of surgical intervention provided by the cerebrovascular outpatient clinic, with attached carotid ultrasound and angiography results.
Surgical anesthesia:
- Superficial and deep cervical block with 3.75% ropivacaine (50ml ropivacaine 3.75%) (incase of allergy bupivacaine should be used)
- Securing venous catheter, infusion of Lactated-Ringer or Voluven solution.
- In case of pain topical administration of Lidocaine by the surgeon, intravenous administration of 25-50ug Fentanyl or 1 vial of Algopyrin.
Intraoperative measurements:
- Bilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention.
- Recording mean arterial pressure with each TCD measurement.
- Recording cerebral saturation (INVOS) with each TCD measurement.
- Recording any anti-hypertensive therapy in the postoperative phase.
- Recording heart rate.
- Recording arterial oxygen saturation.
- Recording the patients' neurological status with each TCD measurement and continuous neurological monitoring while the internal carotid artery is clamped.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients without neurological symptoms | – | Device: transcranial Doppler (TCD) and INVOS monitorcarotid endarterectomy patients who dont'have any neurological symptoms after carotid clamping |
| patients with neurological symptoms | – | Device: transcranial Doppler (TCD) and INVOS monitorcarotid endarterectomy patients who have new neurological symptoms after carotid clamping |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100 patients awaiting carotid artery endarterectomy carried out in regional anesthesia. * Age: patients over 18 years. * Gender: both female and male patients are included in the study.
Key inclusion criteria (6 listed)
- 100 patients awaiting carotid artery endarterectomy carried out in regional anesthesia.
- Age: patients over 18 years.
- Gender: both female and male patients are included in the study.
- Medical equipment: venous catheter, arterial catheter for invasive blood pressure monitoring.
- Bilateral continuous measurement of the middle cerebral arteries with Transcranial Doppler.
Key exclusion criteria (3 listed)
- Allergy to ropivacaine, bupivacaine.
- Patients who does not consent to the awake surgery or does not sign the informed consent of the study.
- If the patient is either psychologically or neurologically unsuitable for the awake surgery.
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 |
|---|---|---|
| transcranial Doppler (TCD) and INVOS monitorBilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention. | Device | patients with neurological symptoms, patients without neurological symptoms |
Primary outcome
to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms
Time frame: 15 month
(aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms Recording mean arterial flow velocity with each TCD measurement.
to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms
Time frame: 15 month
Recording cerebral saturation (INVOS) with each measurement.
1 secondary outcome
the degree of change in the measured parameters during clamp and declamp after the internal carotid artery is clamped, if there is any difference between the operated and non-operated sides?
Time frame: 15 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Results publication: PubMed 7655972Williams IM, Mead G, Picton AJ, Farrell A, Mortimer AJ, McCollum CN. The influence of contralateral carotid stenosis and occlusion on cerebral oxygen saturation during carotid artery surgery. Eur J Vasc Endovasc Surg. 1995 Aug;10(2):198-206. doi: 10.1016/s1078-5884(05)80112-1.
- Results publication: PubMed 23973277Pennekamp CW, Immink RV, den Ruijter HM, Kappelle LJ, Bots ML, Buhre WF, Moll FL, de Borst GJ. Near-infrared spectroscopy to indicate selective shunt use during carotid endarterectomy. Eur J Vasc Endovasc Surg. 2013 Oct;46(4):397-403. doi: 10.1016/j.ejvs.2013.07.007. Epub 2013 Aug 21.
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.
Béla Fülesdi, MD,PhD,DSci principal investigator
Hungary University of Debrecen Debrecen, Hungary, 4032
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Oxygen Saturation,MCA Velocity,Intraoperative Neurological Symptoms During Carotid Endarterectomy, run by University of Debrecen at 2 sites in Hungary.
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 6 inclusion and 3 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. 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 Zoltán Mr Gyöngyösi, Md (+3630/2883970, zozman77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms (time frame: 15 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02665104, which also lists 2 linked publications.
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 13 Mar 2017.