Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-30 @ 5:09 AM
Study NCT ID:
NCT00795535
Status:
COMPLETED
Last Update Posted:
2015-02-09
First Post:
2008-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Heart Rate Variability in Trauma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kproctor@med.miami.edu', 'phone': '305-355-4960', 'title': 'Kenneth Proctor, PhD, Professor of Surgery', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Duration of transport from injury to hospital', 'eventGroups': [{'id': 'EG000', 'title': 'Trauma Patients', 'description': 'Patients transported to the trauma center by helicopter', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Base Deficit </= -6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Patients', 'description': 'Patients transported to the trauma center by helicopter'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Upon arrival to the hospital', 'description': 'Indicator for volume deficit and resuscitation. Number of participants with Base Deficit \\</= -6 is reported. Base deficit is the absolute difference of the base deficit from its normal range (-2 to 2), and is used as an indicator for traumatic injuries. A base deficit \\</= - 6 signifies volume deficit and the need for volume resuscitation with fluids, blood or blood products either alone or in combination.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '75 patients with complete HRV and trauma registry data'}, {'type': 'PRIMARY', 'title': 'Serious Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Patients', 'description': 'Patients transported to the trauma center by helicopter'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Upon arrival to the hospital', 'description': 'A patient was classified as seriously injured when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '75 patients with complete HRV and trauma registry data'}, {'type': 'PRIMARY', 'title': 'Life Saving Intervention in the Operating Room.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Patients', 'description': 'Patients transported to the trauma center by helicopter'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Upon arrival to the hospital', 'description': 'A patient was classified as having a life saving intervention in the operating room when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '75 patients with complete HRV and trauma registry data'}, {'type': 'PRIMARY', 'title': 'SDNN: Standard Deviation of the Normal-to-normal R-R Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Patients', 'description': 'Patients transported to the trauma center by helicopter'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '31', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.15', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'To avoid overfitting the models, only predictors with p\\<0.15 were included in the final models.', 'groupDescription': 'Wilcoxon rank sum tests were used to compare continuous predictors, whereas chi-square tests were used to compare dichotomized predictors between those with and without serious injury. Test characteristics (specificity and positive/negative predictive values) of continuous predictors were reported based on threshold values chosen for a minimum of 80% of sensitivity. Multiple logistic regression models were used to examine the marginal effect of each predictor.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Upon arrival to the hospital', 'description': 'A determination of HRV derived from the time domain of a standard electrocardiogram, primarily determined by measuring the randomness of the exact occurrence of when one R wave follows a preceding R wave.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trauma Patients', 'description': 'Patients transported to the trauma center by helicopter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'incomplete data and technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Trauma Patients', 'description': 'Patients transported to the trauma center by helicopter'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '75 patients with complete HRV and trauma registry data'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-04', 'studyFirstSubmitDate': '2008-11-19', 'resultsFirstSubmitDate': '2014-12-12', 'studyFirstSubmitQcDate': '2008-11-19', 'lastUpdatePostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-12', 'studyFirstPostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Base Deficit </= -6', 'timeFrame': 'Upon arrival to the hospital', 'description': 'Indicator for volume deficit and resuscitation. Number of participants with Base Deficit \\</= -6 is reported. Base deficit is the absolute difference of the base deficit from its normal range (-2 to 2), and is used as an indicator for traumatic injuries. A base deficit \\</= - 6 signifies volume deficit and the need for volume resuscitation with fluids, blood or blood products either alone or in combination.'}, {'measure': 'Serious Injury', 'timeFrame': 'Upon arrival to the hospital', 'description': 'A patient was classified as seriously injured when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.'}, {'measure': 'Life Saving Intervention in the Operating Room.', 'timeFrame': 'Upon arrival to the hospital', 'description': 'A patient was classified as having a life saving intervention in the operating room when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.'}, {'measure': 'SDNN: Standard Deviation of the Normal-to-normal R-R Interval', 'timeFrame': 'Upon arrival to the hospital', 'description': 'A determination of HRV derived from the time domain of a standard electrocardiogram, primarily determined by measuring the randomness of the exact occurrence of when one R wave follows a preceding R wave.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Injury'], 'conditions': ['Trauma']}, 'referencesModule': {'references': [{'pmid': '17622866', 'type': 'BACKGROUND', 'citation': 'Proctor KG, Atapattu SA, Duncan RC. Heart rate variability index in trauma patients. J Trauma. 2007 Jul;63(1):33-43. doi: 10.1097/01.ta.0000251593.32396.df.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop new triage tool for trauma patients based on HRV. EKG will be prospectively measured in trauma patients in two locations: in the prehospital setting (the field and during transport by helicopter) and in the hospital setting. In each case HRV will be derived from the EKG signal, will be correlated with other non-invasive signals (e.g. near infrared spectroscopy (NIR), and bispectral EEG (BIS)), along with other routinely measured variables (blood pressure, respiratory rate, pulse oximetry, etc), will be correlated with injury severity and day of discharge. An algorithm will be constructed using multiple linear regression. The hypotheses are:\n\n1. reduced HRV in the field correlates with bad outcome;\n2. the specificity and efficiency of HRV as a screening tool can be improved by controlling factors such as heart rate, age, gender, respiratory rate, and pulse oxygen saturation;\n3. an easy to interpret HRV index can be derived that can be used for trauma triage or diagnosis.', 'detailedDescription': 'The eligible study population will be comprised of patients who meet level 1 trauma criteria and are transported by helicopter to Ryder Trauma Center or who are already admitted to the trauma center for presumptive traumatic brain injury. In addition to the EKG, trauma patients may also be connected to either an non-invasive NIR Monitor, which provides real-time information about perfusion status and/or a bispectral EEG monitor, which provides real-time information about brain metabolic activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All trauma patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who meet level 1 trauma criteria and are transported by helicopter to Ryder Trauma Center\n* An additional study population will be comprised of patients already admitted to the trauma center for presumptive Traumtaic Brain Injury\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00795535', 'acronym': 'HRV', 'briefTitle': 'Heart Rate Variability in Trauma Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Heart Rate Variability in Trauma Patients', 'orgStudyIdInfo': {'id': '20060938'}}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Ryder Trauma Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Kenneth G Proctor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kenneth Proctor', 'investigatorAffiliation': 'University of Miami'}}}}