Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-02-06 @ 1:29 PM
Study NCT ID:
NCT04144166
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2019-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Capillary Refill Index
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TLi2@northwell.edu', 'phone': '(516) 562-1513', 'title': 'Director of Clinical Research for Emergency Medicine', 'organization': 'North Shore University Hospital'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Sample size: Number of required sample size was 54. Detail of the sample size calculation is described in the clinical protocol document. Actual results were 57 subjects, so results are statistically valid with respect to sample size.\n\nParticipant flow: Subject discovered to be pregnant and removed from study. Since study is non-invasive and minimal risk, subject and fetus were not exposed to any additional risks. Hospital IRB was notified of deviation and did not require other reporting.'}}, 'adverseEventsModule': {'timeFrame': '30 min', 'description': 'All adverse events (all cause mortality, serious-adverse, other - not serious) reported to P.I. in written form via data collection form', 'eventGroups': [{'id': 'EG000', 'title': 'All Subjects', 'description': 'Adult emergency department (ED) patients, both males and females without regards to ethnic and racial backgrounds. CRT and CRI measurements were conducted with following methods for each subject in a relaxed position (seated or lying down) with relaxed hands. The subject\'s most accessible hand (right or left) was used. Each measurement of visual CRT and device CRI were performed alternately and were repeated three times each for a total of six compressions per subject.\n\nVisual CRT measurement using a stopwatch An investigator (an ED physician) compressed the fingertip of the subject\'s index or middle finger for five seconds, signaled by "start compression" and "release compression" beep sounds. When the fingertip was released from the compression, the investigator began the visual CRT measurement. The investigator held a stopwatch in the hand that did not perform the compression and used this stopwatch to measure CRT.\n\nCRI measurement by the investigational device The SpO2 sensor probe was applied to either the index or middle fingertip of the same hand of the subject used in the CRT measurement, depending upon which fingertip was compressed in the CRT measurement. The investigator who measured the visual CRT was blinded from the measured value of the CRI measurement.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Predictive Capability of the Altered Peripheral Perfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensitivity and Specificity to Predict Low Peripheral Perfusion', 'description': 'Ability to differentiate altered peripheral perfusion with a CRI cutoff value of 3.37 s for low CRT (\\> 2 s) and very low CRT (\\> 3 s)'}], 'classes': [{'title': 'Optimal CRI (3.37 s) low peripheral perfusion sensitivity', 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.71', 'upperLimit': '0.98'}]}]}, {'title': 'Optimal CRI (3.37 s) low peripheral perfusion specificity', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '1.00'}]}]}, {'title': 'Optimal CRI (3.37 s) very low peripheral perfusion sensitivity', 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '1.00'}]}]}, {'title': 'Optimal CRI (3.37 s) very low peripheral perfusion specificity', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '0.93'}]}]}, {'title': 'AUC low peripheral perfusion (> 2 s)', 'categories': [{'measurements': [{'value': '0.986', 'groupId': 'OG000', 'lowerLimit': '0.944', 'upperLimit': '0.997'}]}]}, {'title': 'AUC very low peripheral perfusion (> 3 s)', 'categories': [{'measurements': [{'value': '0.910', 'groupId': 'OG000', 'lowerLimit': '0.807', 'upperLimit': '0.960'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '< 30 min *right after enrollment', 'description': 'The area under the curve (AUC) of the receiver operator characteristic (ROC) curve analysis on CRI values to predict probability of altered peripheral perfusion determined with the CRT test.', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Correlation of Device CRI to Conventional (Visual) CRT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Correlation Between CRI and CRT Values', 'description': "Spearman's correlation method to determine relationship between median device CRI and median device CRT measurements."}], 'classes': [{'categories': [{'measurements': [{'value': '0.866', 'groupId': 'OG000', 'lowerLimit': '0.782', 'upperLimit': '0.919'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'Mean value for visual CRT and median value for device CRI were calculated for each participant. 3 values were measured (each) for CRT and CRI. Mean value is equal to SUM(m1,m2,m3)/3.\n\nMedian value was then calculated for the set (57) of calculated mean visual CRT and mean device CRI. Median value is equal to the middle value of the series of mean values. All measurements are in units of seconds.', 'statisticalMethod': 'See above', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'See above'}], 'paramType': 'NUMBER', 'timeFrame': '< 30 min *right after enrollment', 'description': "Spearman's correlation coefficient to assess the correlation between CRI and CRT values.", 'unitOfMeasure': "Spearman's correlation coefficient", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Independence of Age Impact on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subject >= 60 Years', 'description': 'All subject \\>= 60 years'}, {'id': 'OG001', 'title': 'All Subjects < 60 Years', 'description': 'All subjects \\< 60 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.992', 'groupId': 'OG000', 'lowerLimit': '0.888', 'upperLimit': '1.000'}, {'value': '0.982', 'groupId': 'OG001', 'lowerLimit': '0.901', 'upperLimit': '1.000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '< 30 min *right after enrollment', 'description': 'Demonstrate that age is not a variant for CRI measurement', 'unitOfMeasure': 'probabllity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients \\< 60 years vs. \\>= 60 years'}, {'type': 'POST_HOC', 'title': 'Independence of Fitzpatrick Skin Tone Score on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects With Fitzpatrick Skin Tone Score of 1, 2 or 3', 'description': 'All subjects with FItzpatrick skin tone score of 1, 2 or 3'}, {'id': 'OG001', 'title': 'All Subjects With Fitzpatrick Skin Tone Score of 4, 5 or 6', 'description': 'All subjects with FItzpatrick skin tone score of 4, 5 or 6'}], 'classes': [{'categories': [{'measurements': [{'value': '0.994', 'groupId': 'OG000', 'lowerLimit': '0.993', 'upperLimit': '1.00'}, {'value': '0.981', 'groupId': 'OG001', 'lowerLimit': '0.820', 'upperLimit': '0.998'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '< 30 min *right after enrollment', 'description': 'Demonstrate that skin tone is not a variant for CRI measurement', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Fitzpatrick skin tone score of 1, 2 or 3 vs. scores of 4, 5, or 6'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects', 'description': 'Adult emergency department (ED) patients, both males and females without regards to ethnic and racial backgrounds. CRT and CRI measurements were conducted with following methods for each subject in a relaxed position (seated or lying down) with relaxed hands. The subject\'s most accessible hand (right or left) was used. Each measurement of visual CRT and device CRI were performed alternately and were repeated three times each for a total of six compressions per subject.\n\nVisual CRT measurement using a stopwatch An investigator (an ED physician) compressed the fingertip of the subject\'s index or middle finger for five seconds, signaled by "start compression" and "release compression" beep sounds. When the fingertip was released from the compression, the investigator began the visual CRT measurement. The investigator held a stopwatch in the hand that did not perform the compression and used this stopwatch to measure CRT.\n\nCRI measurement by the investigational device The SpO2 sensor probe was applied to either the index or middle fingertip of the same hand of the subject used in the CRT measurement, depending upon which fingertip was compressed in the CRT measurement. The investigator who measured the visual CRT was blinded from the measured value of the CRI measurement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Discharged before study start', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Nail polish could not be removed from finger', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'Adult emergency department (ED) patients, both males and females without regards to ethnic and racial backgrounds. CRT and CRI measurements were conducted with following methods for each subject in a relaxed position (seated or lying down) with relaxed hands. The subject\'s most accessible hand (right or left) was used. Each measurement of visual CRT and device CRI were performed alternately and were repeated three times each for a total of six compressions per subject.\n\nVisual CRT measurement using a stopwatch An investigator (an ED physician) compressed the fingertip of the subject\'s index or middle finger for five seconds, signaled by "start compression" and "release compression" beep sounds. When the fingertip was released from the compression, the investigator began the visual CRT measurement. The investigator held a stopwatch in the hand that did not perform the compression and used this stopwatch to measure CRT.\n\nCRI measurement by the investigational device The SpO2 sensor probe was applied to either the index or middle fingertip of the same hand of the subject used in the CRT measurement, depending upon which fingertip was compressed in the CRT measurement. The investigator who measured the visual CRT was blinded from the measured value of the CRI measurement.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'groupId': 'BG000', 'lowerLimit': '38.0', 'upperLimit': '66.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other/Multiracial', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'No designation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick Skin Tone Scale', 'classes': [{'title': 'Fitzpatrick skin tone - 1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Fitzpatrick skin tone - 2', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Fitzpatrick skin tone - 3', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Fitzpatrick skin tone - 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Fitzpatrick skin tone - 5', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Fitzpatrick skin tone - 6', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Fitzpatrick skin tone scale is a numerical classification schema for human skin color. The scales range from 1 - fairest skin to 6 - very dark pigment skin. A visual chart comparison was used for assignment of each subject. Results (see later) only addressed a comparison of subjects in Fitzpatrick 1, 2 or 3 versus subjects in Fitzpatrick 4, 5 of 6.', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-02', 'size': 757059, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-09T09:21', 'hasProtocol': True}, {'date': '2019-09-27', 'size': 470361, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-11-09T09:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2019-10-28', 'resultsFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-01', 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive Capability of the Altered Peripheral Perfusion', 'timeFrame': '< 30 min *right after enrollment', 'description': 'The area under the curve (AUC) of the receiver operator characteristic (ROC) curve analysis on CRI values to predict probability of altered peripheral perfusion determined with the CRT test.'}], 'secondaryOutcomes': [{'measure': 'Correlation of Device CRI to Conventional (Visual) CRT', 'timeFrame': '< 30 min *right after enrollment', 'description': "Spearman's correlation coefficient to assess the correlation between CRI and CRT values."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['capillary refill time', 'peripheral perfusion'], 'conditions': ['Perfusion; Complications']}, 'descriptionModule': {'briefSummary': 'Comparison of a peripheral perfusion assessment method using a pulse oximeter to the conventional capillary refill time visually assessed by a clinician.', 'detailedDescription': 'A new technology, capillary refill index (CRI), to assess peripheral perfusion status quantitatively using pulse oximeter waveforms is being developed. The conventional capillary refill time (CRT) is widely used in clinical settings as a gold standard to assess peripheral perfusion.\n\nThe objective of this study is to evaluate the capability of CRI to predict altered peripheral perfusion determined with the conventional CRT test. Predictive capability of CRI needs to be assessed to achieve a goal to provide clinicians with an alternative method to the conventional CRT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults in ED or admitted to ICU', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Individuals 18 years of age or older\n2. Patients who present to the ED or who are admitted to the ICU of North Shore University Hospital (NSUH)\n\nExclusion Criteria:\n\n1. Pregnant\n2. Prisoners\n3. Finger, hand or forearm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor\n4. Patients' deemed clinically unstable by the clinical team"}, 'identificationModule': {'nctId': 'NCT04144166', 'acronym': 'CRI', 'briefTitle': 'Evaluation of Capillary Refill Index', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nihon Kohden'}, 'officialTitle': 'Evaluation of Capillary Refill Index', 'orgStudyIdInfo': {'id': 'CS-011-004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'capillary refill index (CRI)', 'type': 'DEVICE', 'description': 'a waveform analysis method using a pulse oximeter to assess peripheral perfusion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Timmy Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Admin Dir Clinical Research Emergency Medicine, Northwell Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nihon Kohden', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}