Condition or disease | Intervention/treatment | Phase |
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Carotid Disease | Device: NeurOS | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Patients will have NeurOS pads placed on their foreheads. Continuous monitoring of arterial blood pressure, cerebral oxygenation and brain blood volume index for the whole length of surgery will be recorded and saved in a USB drive for retrieval and analysis. Key point data include: Baseline, Anesthesia Induction, Incision, Carotid Clamping, Clamp Release and Skin Closure. These key points data will be extracted for analysis. |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Study of Regional Cerebral Oxygenation and Brain Blood Volume Changes During Carotid Endarterectomy Using the NeurOS System |
Estimated Study Start Date : | July 1, 2021 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | December 31, 2023 |
Arm | Intervention/treatment |
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Experimental: NeurOS Group
Apply the single use NeurOS cerebral oximetry sensor adhesive onto patients' head who are going to have CEA surgery in the operating room before anesthesia induction.
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Device: NeurOS
NeurOS system pads will be placed on patients' head for monitoring.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Having carotid endarterectomy at Jewish Hospital, Louisville, KY Agree to study protocol No allergy to either INOVS or NeurOS system pads
Exclusion Criteria:
Refusal to participate Emergency surgery Allergy to either INOVS or NeurOS system pads
Contact: Jiapeng Huang, MD, PhD | 5024321582 | j0huan03@louisville.edu |
United States, Kentucky | |
Jewish Hospital | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Jiapeng Huang, MD, PhD 502-432-1582 jiapeng.huang@louisville.edu |
Principal Investigator: | Jiapeng Huang, MD, PhD | University of Louisville |
Tracking Information | |||||||
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First Submitted Date ICMJE | June 6, 2019 | ||||||
First Posted Date ICMJE | June 11, 2019 | ||||||
Last Update Posted Date | February 9, 2021 | ||||||
Estimated Study Start Date ICMJE | July 1, 2021 | ||||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Regional Cerebral Oxygenation [ Time Frame: From the beginning of surgery until the end of surgery for each patient enrolled ] Regional Cerebral Oxygenation during Carotid Endarterectomy
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
NeurOS Brain Blood Volume [ Time Frame: From the beginning of surgery until the end of surgery for each patient enrolled ] NeurOS Brain Blood Volume during Carotid Endarterectomy
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study of Regional Cerebral Oxygenation and Brain Blood Volume Changes During Carotid Endarterectomy Using the NeurOS System | ||||||
Official Title ICMJE | Study of Regional Cerebral Oxygenation and Brain Blood Volume Changes During Carotid Endarterectomy Using the NeurOS System | ||||||
Brief Summary | Study of Regional cerebral Oxygenation and Brain Blood Volume changes during Carotid Endarterectomy using the NeurOS system | ||||||
Detailed Description |
Cerebral autoregulation was found to be impaired in carotid stenosis patients. Recent research found that NIRS allows continuous non-invasive monitoring of cerebral oxygenation during CEA, with high sensitivity and acceptable specificity in predicting cerebral ischemia and the need for shunting, which makes it an attractive alternative to stump pressure. Regional cerebral oxygenation provides a clinically acceptable surrogate of cerebral blood flow (CBF) for clinical autoregulation monitoring. Monitoring CBF autoregulation with rSO2 has many clinically attractive features, including the following: It is noninvasive, monitoring requires little caregiver intervention, and it has sufficient resolution to discriminate the lower autoregulatory threshold to prevent brain ischemia. On the other hand, simply raising mean blood pressure targets, however, may not necessarily be beneficial because for some individuals this may result in blood pressure above the upper limit of autoregulation, which potentially could lead to cerebral hyperperfusion, increasing cerebral embolic load and/or enhancing cerebral edema in the setting of systemic inflammatory response to cardiac surgery. Individualizing blood pressure during CPB based on physiological endpoints such as rSO2 monitoring, rather than empiric targets, may provide a means for modifying the risk for renal injury and major organ morbidity and possibly mortality. In patients undergoing combined CEA and CABG surgery, it was found that the utility of NIRS could compliment patient selection for CEA as well as for individual patient management during. The brain blood volume changes during CEA has not been defined and would be significantly reduced by carotid artery clamping during CEA. Abnormalities of the circle of Willis would contribute to reduced brain blood volume. The combination of rSO2 and cerebral blood volume would be very helpful to prevent mal-perfusion of either side of the brain. Postoperative delirium could happen after CEA due to reperfusion of the previously ischemic regions of the brain, regulation of cerebral blood volume after CEA would also prove beneficial to prevent postoperative delirium. Problem Statement: Disposable rSO2 sensors are costly and is becoming a rate limiting factor hindering its widespread clinical use. Reusable sensors like NeurOS cerebral oximetry are only a fraction of cost with similar performances in healthy volunteers. We will use NeurOS in accordance with its approved labeling and indications by FDA. CEA surgery has significant variations and great clinical importance of cerebral oxygenation during different stages of surgery. Blood volume changes before, during and after CEA have not been studied previously and could provide critical information to prevent postoperative cognitive changes. The NeurOS system calculates the sum of attenuation of two wavelengths to provide brain blood volume index (BVI) continuously. Patients presenting for carotid endarterectomy face two challenges during surgery. First, how to protect the brain when the carotid artery is clamped, meaning no blood flow to that side of the brain from this carotid artery. Second, how to prevent hyperemia when the carotid artery is open and might provide too much blood flow to the brain. Our aim is to study the cerebral oxygenation and brain blood volume changes during carotid endarterectomy and identify whether they are related to clinical outcomes. 3. Objectives:
4. Study Design/Methodology: Patients will have NeurOS pads placed on their foreheads. Continuous monitoring of arterial blood pressure, cerebral oxygenation and brain blood volume index for the whole length of surgery will be recorded and saved in a USB drive for retrieval and analysis. Key point data include: Baseline, Anesthesia Induction, Incision, Carotid Clamping, Clamp Release and Skin Closure. These key points data will be extracted for analysis.
5. Subject Recruitment Methods: All patients presenting to Jewish Hospital for CEA surgery will be contacted for potential recruitment on the day of surgery in the preoperative area. 6. Informed Consent Process/Complete Waiver Process: Informed consent will be provided to all participants. 7. Research Procedures: In all consented patients, baseline cerebral oxygenation and brain blood volume index will be obtained at room air or baseline oxygen requirement level in the NeurOS systems. Both NeurOS rSO2 and brain blood volume indexes will be continuously recorded and saved in the respective system throughout the whole CEA surgery. General anesthesia will be induced by using O2 administered via face mask and IV fentanyl 1μg/ kg, propofol 2-3mg/kg and rocuronium 1mg/kg. Maintenance of anesthesia was achieved with inhaled isoflurane in air/oxygen mixture and muscle relaxation using intermittent boluses of rocuronium. Fentanyl will be used as supplemental analgesia. Normocapnic ventilation was maintained. Upon completion of surgery, titrated doses of protamine will be administered to reverse the anticoagulant action of heparin, targeting to achieve baseline preoperative Activated clotting Time. After the surgery, all rSO2 and brain blood volume index data are downloaded into an encrypted USB drive for analysis and storage. 8. Minimizing Risks:
9. Plan for Analysis of Results:
Indicate what information (records, data, etc.) will be recorded and whether use will be made of existing records or data: Cerebral oxygenation and brain blood volume. They will be recorded in the medical charts. Explain why this information is needed to conduct the study: These data are necessary to identify outcomes for these patients. Specify how the data will be de-identified (if applicable), who has access to the data, where the data will be stored and how the researcher will protect both the data with respect to privacy and confidentiality. Address physical security measures (e.g., locked facility, limited access); data security (e.g., password-protection, data encryption); safeguards to protect identifiable research information (e.g., coding or links): Once required information is collected, HIPPA information will be deleted. All HIPPA related information will be stored in a private computer in a password protected computer. No links will be provided to the public. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Patients will have NeurOS pads placed on their foreheads. Continuous monitoring of arterial blood pressure, cerebral oxygenation and brain blood volume index for the whole length of surgery will be recorded and saved in a USB drive for retrieval and analysis. Key point data include: Baseline, Anesthesia Induction, Incision, Carotid Clamping, Clamp Release and Skin Closure. These key points data will be extracted for analysis. Masking: None (Open Label)Primary Purpose: Diagnostic |
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Condition ICMJE | Carotid Disease | ||||||
Intervention ICMJE | Device: NeurOS
NeurOS system pads will be placed on patients' head for monitoring.
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Study Arms ICMJE | Experimental: NeurOS Group
Apply the single use NeurOS cerebral oximetry sensor adhesive onto patients' head who are going to have CEA surgery in the operating room before anesthesia induction.
Intervention: Device: NeurOS
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
100 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Having carotid endarterectomy at Jewish Hospital, Louisville, KY Agree to study protocol No allergy to either INOVS or NeurOS system pads Exclusion Criteria: Refusal to participate Emergency surgery Allergy to either INOVS or NeurOS system pads |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03981757 | ||||||
Other Study ID Numbers ICMJE | 19.0273 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Jiapeng Huang, University of Louisville | ||||||
Study Sponsor ICMJE | University of Louisville | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | University of Louisville | ||||||
Verification Date | February 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |