Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT03907904
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2019-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous, Non-invasive Monitoring of Intraoperative Cerebral Perfusion and Oxidative Metabolism (CPOM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain cytochrome C oxidase level.', 'timeFrame': 'Intraoperative', 'description': 'The cytochrome C oxidase level which reflects the brain oxidative metabolism will be measured by a CPOM Optical Neuromonitor.'}, {'measure': 'Brain saturation (ScO2)', 'timeFrame': 'Intraoperative', 'description': 'The brain saturation (ScO2) (%) will be measured by a CPOM Optical Neuromonitor.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intraoperative/methods* Oximetry/methods* Oxygen/metabolism', 'brain/metabolism', 'brain chemistry', 'cerebrovascular circulation', 'humans', 'monitoring, intraoperative/methods', 'oximetry/methods', 'oxygen/metabolism'], 'conditions': ['Brain Hypoxia Ischemia']}, 'referencesModule': {'references': [{'pmid': '27411110', 'type': 'BACKGROUND', 'citation': 'Bale G, Elwell CE, Tachtsidis I. Errata: From Jobsis to the present day: a review of clinical near-infrared spectroscopy measurements of cerebral cytochrome-c-oxidase. J Biomed Opt. 2016 Sep;21(9):099801. doi: 10.1117/1.JBO.21.9.099801. No abstract available.'}, {'pmid': '28685438', 'type': 'BACKGROUND', 'citation': 'de Roever I, Bale G, Cooper RJ, Tachtsidis I. Functional NIRS Measurement of Cytochrome-C-Oxidase Demonstrates a More Brain-Specific Marker of Frontal Lobe Activation Compared to the Haemoglobins. Adv Exp Med Biol. 2017;977:141-147. doi: 10.1007/978-3-319-55231-6_19.'}, {'pmid': '30258675', 'type': 'BACKGROUND', 'citation': 'Rajaram A, Bale G, Kewin M, Morrison LB, Tachtsidis I, St Lawrence K, Diop M. Simultaneous monitoring of cerebral perfusion and cytochrome c oxidase by combining broadband near-infrared spectroscopy and diffuse correlation spectroscopy. Biomed Opt Express. 2018 May 10;9(6):2588-2603. doi: 10.1364/BOE.9.002588. eCollection 2018 Jun 1.'}, {'pmid': '26504641', 'type': 'BACKGROUND', 'citation': 'Diop M, Kishimoto J, Toronov V, Lee DS, St Lawrence K. Development of a combined broadband near-infrared and diffusion correlation system for monitoring cerebral blood flow and oxidative metabolism in preterm infants. Biomed Opt Express. 2015 Sep 10;6(10):3907-18. doi: 10.1364/BOE.6.003907. eCollection 2015 Oct 1.'}, {'pmid': '17179242', 'type': 'BACKGROUND', 'citation': 'Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.'}, {'pmid': '22343469', 'type': 'BACKGROUND', 'citation': 'Davie SN, Grocott HP. Impact of extracranial contamination on regional cerebral oxygen saturation: a comparison of three cerebral oximetry technologies. Anesthesiology. 2012 Apr;116(4):834-40. doi: 10.1097/ALN.0b013e31824c00d7.'}, {'pmid': '24651237', 'type': 'BACKGROUND', 'citation': 'Ogoh S, Sato K, Okazaki K, Miyamoto T, Secher F, Sorensen H, Rasmussen P, Secher NH. A decrease in spatially resolved near-infrared spectroscopy-determined frontal lobe tissue oxygenation by phenylephrine reflects reduced skin blood flow. Anesth Analg. 2014 Apr;118(4):823-9. doi: 10.1213/ANE.0000000000000145.'}, {'pmid': '23543201', 'type': 'BACKGROUND', 'citation': 'Murkin JM. Is it better to shine a light, or rather to curse the darkness? Cerebral near-infrared spectroscopy and cardiac surgery. Eur J Cardiothorac Surg. 2013 Jun;43(6):1081-3. doi: 10.1093/ejcts/ezt186. Epub 2013 Mar 29. No abstract available.'}, {'pmid': '28293809', 'type': 'BACKGROUND', 'citation': 'Olesen ND, Sorensen H, Ambrus R, Svendsen LB, Lund A, Secher NH. A mesenteric traction syndrome affects near-infrared spectroscopy evaluated cerebral oxygenation because skin blood flow increases. J Clin Monit Comput. 2018 Apr;32(2):261-268. doi: 10.1007/s10877-017-0014-2. Epub 2017 Mar 14.'}, {'pmid': '23959202', 'type': 'BACKGROUND', 'citation': 'Bainbridge A, Tachtsidis I, Faulkner SD, Price D, Zhu T, Baer E, Broad KD, Thomas DL, Cady EB, Robertson NJ, Golay X. Brain mitochondrial oxidative metabolism during and after cerebral hypoxia-ischemia studied by simultaneous phosphorus magnetic-resonance and broadband near-infrared spectroscopy. Neuroimage. 2014 Nov 15;102 Pt 1:173-83. doi: 10.1016/j.neuroimage.2013.08.016. Epub 2013 Aug 17.'}, {'pmid': '18759572', 'type': 'BACKGROUND', 'citation': 'Tisdall MM, Tachtsidis I, Leung TS, Elwell CE, Smith M. Increase in cerebral aerobic metabolism by normobaric hyperoxia after traumatic brain injury. J Neurosurg. 2008 Sep;109(3):424-32. doi: 10.3171/JNS/2008/109/9/0424.'}, {'pmid': '21750781', 'type': 'BACKGROUND', 'citation': 'Diop M, Verdecchia K, Lee TY, St Lawrence K. Calibration of diffuse correlation spectroscopy with a time-resolved near-infrared technique to yield absolute cerebral blood flow measurements. Biomed Opt Express. 2011 Jul 1;2(7):2068-81. doi: 10.1364/BOE.2.002068. Epub 2011 Jun 28.'}, {'pmid': '23770408', 'type': 'BACKGROUND', 'citation': 'Durduran T, Yodh AG. Diffuse correlation spectroscopy for non-invasive, micro-vascular cerebral blood flow measurement. Neuroimage. 2014 Jan 15;85 Pt 1(0 1):51-63. doi: 10.1016/j.neuroimage.2013.06.017. Epub 2013 Jun 14.'}, {'pmid': '26384626', 'type': 'BACKGROUND', 'citation': 'Murkin JM, Kamar M, Silman Z, Balberg M, Adams SJ. Intraoperative Cerebral Autoregulation Assessment Using Ultrasound-Tagged Near-Infrared-Based Cerebral Blood Flow in Comparison to Transcranial Doppler Cerebral Flow Velocity: A Pilot Study. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1187-93. doi: 10.1053/j.jvca.2015.05.201. Epub 2015 May 27.'}, {'type': 'BACKGROUND', 'citation': 'McManus R, Froats E, St Lawrence K, Vanuum S, Diop M. Dynamic Relationship between Cerebral Blood Flow and Symptoms of Hypoglycemia. Canadian Journal of Diabetes 42(5): S12, 2018.'}, {'pmid': '6439135', 'type': 'BACKGROUND', 'citation': 'Govier AV, Reves JG, McKay RD, Karp RB, Zorn GL, Morawetz RB, Smith LR, Adams M, Freeman AM. Factors and their influence on regional cerebral blood flow during nonpulsatile cardiopulmonary bypass. Ann Thorac Surg. 1984 Dec;38(6):592-600. doi: 10.1016/s0003-4975(10)62316-8.'}, {'pmid': '3985707', 'type': 'BACKGROUND', 'citation': 'Lundar T, Froysaker T, Lindegaard KF, Wiberg J, Lindberg H, Rostad H, Nornes H. Some observations on cerebral perfusion during cardiopulmonary bypass. Ann Thorac Surg. 1985 Apr;39(4):318-23. doi: 10.1016/s0003-4975(10)62621-5.'}, {'pmid': '27699127', 'type': 'BACKGROUND', 'citation': 'Verdecchia K, Diop M, Lee A, Morrison LB, Lee TY, St Lawrence K. Assessment of a multi-layered diffuse correlation spectroscopy method for monitoring cerebral blood flow in adults. Biomed Opt Express. 2016 Aug 24;7(9):3659-3674. doi: 10.1364/BOE.7.003659. eCollection 2016 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'This study uses a CPOM Optical neuromonitor to assess the relationship between brain cytochrome C oxidase, cerebral oxygen saturation and blood pressure during surgery performed under general anesthesia.', 'detailedDescription': 'During various surgical procedures, blood supply to the brain can be jeopardized either due to interruption of flow as occurs during carotid surgery, or due to inadequate arterial pressure which can occur in settings as diverse as heart surgery or shoulder surgery. This is a prospective observational study of brain oxygen levels, brain metabolism and blood pressure in 50 adult surgical patients under general anesthesia using a CPOM Optical neuromonitor.\n\nThis is an observational study. The primary objective of this study is to describe the changes in redox state of brain CCO (reflecting oxidative metabolism), CBFi, and brain tissue oxygen saturation in relation to systemic blood pressure in patients during general anesthesia/cardiopulmonary bypass (CPB). This study represents the first opportunity to assess this combined technology in adult patients and will provide important data to support further investigations in brain-at-risk patients.\n\nThese 50 patients will be used to help the investigators to obtain pilot data about the relationship between brain cytochrome C oxidase (bCCO), cerebral oxygen saturation (ScO2), and blood pressure (especially hypotension) using a CPOM device. Cerebral auto regulation indices will also be determined. No intervention will be applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted for surgery requiring general anesthesia and required to have an arterial line.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult surgical patients (\\>18 year-old) who require general anesthesia for their surgery\n* Patients required an arterial line for his/her procedure\n\nExclusion Criteria:\n\n* Emergency surgery\n* Unable to obtain consent\n* Condition that preclude the use of CPOM monitor (e.g. skin lesion in the forehead)'}, 'identificationModule': {'nctId': 'NCT03907904', 'briefTitle': 'Continuous, Non-invasive Monitoring of Intraoperative Cerebral Perfusion and Oxidative Metabolism (CPOM)', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': 'Continuous, Non-invasive Monitoring of Intraoperative Cerebral Perfusion and Oxidative Metabolism (CPOM): a Knowledge Translation Study.', 'orgStudyIdInfo': {'id': '113650'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CPOM Optical Neuromonitor', 'type': 'DEVICE', 'description': "Prior to induction of anesthesia, the CPOM monitor will be secured to the temporal region of the participant's forehead to measure and record the cerebral hemodynamic data before, during, and following intubation. Hemodynamic, respiratory, body temperature, and anesthetic data will be continuously digitally records. The CPOM device will be detached after extubation in the operative room."}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Jason Chui, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}