Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-03 @ 8:40 PM
Study NCT ID:
NCT03128957
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Correlating Brain Tissue Oxygen and Regional Cerebral Oximetry
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ppicton@med.umich.edu', 'phone': '734 615 9864', 'title': 'Dr. Paul Picton', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Data were collected intraoperatively, and postoperatively for 24 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'Varying Cerebral Oxygenation With Varying Ventilation', 'description': 'Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen\n\nIVOS cerebral oximeter: Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nLicox cerebral oxygenation monitor: Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nCerebral oxygenation: Measuring cerebral oxygenation with varying ventilation strategy', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation Between Regional Cerebral Oximetry (RSO2) and Cerebral Oxygen Tissue Tension (PbrO2).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Varying Cerebral Oxygenation With Varying Ventilation', 'description': 'Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen\n\nIVOS cerebral oximeter: Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nLicox cerebral oxygenation monitor: Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nCerebral oxygenation: Measuring cerebral oxygenation with varying ventilation strategy'}], 'classes': [{'categories': [{'measurements': [{'value': '.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000'], 'groupDescription': "Non-parametric covariance adjusted Spearman's correlation ρ\\_s. To test the Null that Ho: ρ\\_s.=0 vs alternative that Ha: ρ\\_s.≠0, we used a method that calculates the probability that it would be greater than or equal to the observed ρ ̂, given the null hypothesis, by using a permutation test. An advantage of this approach is that it automatically takes into account the number of tied data values in the sample and the way they are treated in computing the rank correlation.", 'statisticalMethod': 'permutation test', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': "Given the non-parametric nature of spearman's correlation coefficient and a small sample we used a permutation test to calculate p-values.", 'nonInferiorityComment': 'Given the small sample permutation are feasible.'}], 'paramType': 'NUMBER', 'timeFrame': 'Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes', 'description': 'Correlation - correlation coefficient between cerebral oxygenation measured by Licox and INVOS oxygen measurement systems subsequent upon changes in ventilation strategy\n\nSpearman correlation describes the strength of the monotonic relationship between two measures and is bounded between -1 and 1. Negative values indicate an inverse relationship while positive values mean that the variables move in tandem.\n\n\\[Example of correlation coefficient in CT.gov: NCT02318667\\]', 'unitOfMeasure': 'Spearman Correlation (rs) Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "One subject's data was identified as an extreme value using the Tuckey Fences approach and was excluded from primary analysis."}, {'type': 'SECONDARY', 'title': 'Changes in PbrO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Varying Cerebral Oxygenation With Varying Ventilation', 'description': 'Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen\n\nIVOS cerebral oximeter: Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nLicox cerebral oxygenation monitor: Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nCerebral oxygenation: Measuring cerebral oxygenation with varying ventilation strategy'}], 'classes': [{'title': 'Set point 1 (FiO2 0.3 and PaCO2 30 mmHg)', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '11.3'}]}]}, {'title': 'Set point 2 (FiO2 1.0 and PaCO2 40 mmHg)', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '43.6'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000'], 'groupDescription': 'Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes', 'description': 'PbrO2 - measured in millimeters of mercury(mmHg); Steady State PbrO2 Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction after Equilibration for each Set Point', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was identified as an extreme value using the Tuckey Fences approach and was excluded from final analysis.'}, {'type': 'SECONDARY', 'title': 'Changes in rSO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Varying Cerebral Oxygenation With Varying Ventilation', 'description': 'Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen\n\nIVOS cerebral oximeter: Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nLicox cerebral oxygenation monitor: Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nCerebral oxygenation: Measuring cerebral oxygenation with varying ventilation strategy'}], 'classes': [{'title': 'Set Point 1 (FiO2 0.3 and PaCO2 30 mmHg)', 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '80.5'}]}]}, {'title': 'Set Point 2 (FiO2 1.0 and PaCO2 40 mmHg)', 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000', 'lowerLimit': '74.0', 'upperLimit': '90.0'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000'], 'groupDescription': 'Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes', 'description': 'rSO2 - %saturation; Steady State rSO2 Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction after Equilibration for each Set Point', 'unitOfMeasure': 'percentage saturation', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was identified as an extreme value using the Tuckey Fences approach and was excluded from final analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Varying Cerebral Oxygenation With Varying Ventilation', 'description': 'Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen\n\nIVOS cerebral oximeter: Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nLicox cerebral oxygenation monitor: Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nCerebral oxygenation: Measuring cerebral oxygenation with varying ventilation strategy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 12 subjects were consented, two were excluded for logistical reasons prior to any data collection.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Varying Cerebral Oxygenation With Varying Ventilation', 'description': 'Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen\n\nIVOS cerebral oximeter: Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nLicox cerebral oxygenation monitor: Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.\n\nCerebral oxygenation: Measuring cerebral oxygenation with varying ventilation strategy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '9.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-10', 'size': 205727, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-17T14:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2017-04-14', 'resultsFirstSubmitDate': '2022-06-25', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-10', 'studyFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between Regional Cerebral Oximetry (RSO2) and Cerebral Oxygen Tissue Tension (PbrO2).', 'timeFrame': 'Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes', 'description': 'Correlation - correlation coefficient between cerebral oxygenation measured by Licox and INVOS oxygen measurement systems subsequent upon changes in ventilation strategy\n\nSpearman correlation describes the strength of the monotonic relationship between two measures and is bounded between -1 and 1. Negative values indicate an inverse relationship while positive values mean that the variables move in tandem.\n\n\\[Example of correlation coefficient in CT.gov: NCT02318667\\]'}], 'secondaryOutcomes': [{'measure': 'Changes in PbrO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction', 'timeFrame': 'Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes', 'description': 'PbrO2 - measured in millimeters of mercury(mmHg); Steady State PbrO2 Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction after Equilibration for each Set Point'}, {'measure': 'Changes in rSO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction', 'timeFrame': 'Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes', 'description': 'rSO2 - %saturation; Steady State rSO2 Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction after Equilibration for each Set Point'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Controversy surrounds the use of regional cerebral oximetry (rSO2) as a measure of true cerebral oxygenation because of extracranial signal contamination and unmeasured confounding of cerebral a:v ratio. The measurement of brain tissue oxygen (PbrO2) has been used in routine neurosurgery and has been shown to reliably demonstrate cerebral hypoxia following severe head injury. It is the most direct measure of cerebral oxygenation. Here, we test the hypothesis that there is a correlation between PbrO2 and rSO2 under conditions of varying inspired oxygen fraction and the varying partial pressure of carbon dioxide in arterial blood in uninjured, normal human brain.\n\nPatients who are scheduled for elective removal of secondary cerebral metastases under general anesthesia will be recruited following written informed consent obtained by a study team member during their preoperative evaluation. BIS and rSO2 optodes will be applied, before induction of anesthesia, by a single researcher on both sides of the patient\'s forehead, as recommended by the manufacturer. General anesthesia will be maintained by total intravenous anesthesia (TIVA) with a combination of propofol (80-150 mcg/kg/min) and remifentanil (0.05-0.1 mcg/kg/min) targeted to a Bispectral Index range 40-60 (BIS; Covidien, Boulder, CO). Following craniotomy, the LICOX probe will be placed under direct vision into an area of normal brain within the tumor excision canal by the attending neurosurgeon. During a pause in surgery FIO2 and minute ventilation will be sequentially adjusted to achieve the following pairs of ventilation set points: 1) FIO2 0.3 and paCO2 30mmHg, 2) FIO2 1.0 and paCO2 40mmHg. After ≥5 minutes at each set point FIO2, PaCO2, rSO2 and PbrO2 will be recorded as a "snap-shot".\n\nA sample size of 15 achieves an 80% power with a one-sided type I error of 5% to detect a positive correlation of 0.6 (from the null hypothesis of no correlation) between changes in PbrO2 and changes in rSO2 subsequent on alterations made in ventilation strategy. Correlation will be measured using Pearson\'s Correlation. P values \\< 0.05 will be considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are scheduled for elective removal of secondary cerebral metastases under general anesthesia.\n\nExclusion Criteria:\n\n* Patients will be excluded if they refuse to give consent, have evidence of elevated intracranial pressure on preoperative CT scan, have coagulopathy, are taking therapeutic agents known to increase bleeding risk, have a history of cardiovascular disease, cerebrovascular disease, suffer from respiratory failure, or are not fluent English speakers.'}, 'identificationModule': {'nctId': 'NCT03128957', 'briefTitle': 'Correlating Brain Tissue Oxygen and Regional Cerebral Oximetry', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Correlating Brain Tissue Oxygen Tension (PbrO2) and Regional Cerebral Oximetry (rSO2) in Normal Human Brain Under the Conditions of Changing Ventilation Strategy', 'orgStudyIdInfo': {'id': 'HUM00105648'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Varying cerebral oxygenation with varying ventilation', 'description': 'Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen', 'interventionNames': ['Device: IVOS cerebral oximeter', 'Device: Licox cerebral oxygenation monitor', 'Other: Cerebral oxygenation']}], 'interventions': [{'name': 'IVOS cerebral oximeter', 'type': 'DEVICE', 'description': 'Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.', 'armGroupLabels': ['Varying cerebral oxygenation with varying ventilation']}, {'name': 'Licox cerebral oxygenation monitor', 'type': 'DEVICE', 'description': 'Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.', 'armGroupLabels': ['Varying cerebral oxygenation with varying ventilation']}, {'name': 'Cerebral oxygenation', 'type': 'OTHER', 'description': 'Measuring cerebral oxygenation with varying ventilation strategy', 'armGroupLabels': ['Varying cerebral oxygenation with varying ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Paul Picton, MB ChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Paul Picton', 'investigatorAffiliation': 'University of Michigan'}}}}