Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04757805
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2021-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Giorgio.Veneziano@nationwidechildrens.org', 'phone': '614-722-4200', 'title': 'Giorgio Veneziano, MD', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Spinal Anesthesia', 'description': 'Infants receiving spinal anesthesia for standard of care procedure\n\nUltrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intended Interspace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spinal Anesthesia', 'description': 'Infants receiving spinal anesthesia for standard of care procedure\n\nUltrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.'}], 'classes': [{'title': 'L2-3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'L3-4', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'L4-5', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately prior to spinal anesthesia', 'description': 'The vertebral interspace that the anesthesia provider believes that they had marked \\& identified by manual palpation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Actual Interspace of Provider's Mark", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spinal Anesthesia', 'description': 'Infants receiving spinal anesthesia for standard of care procedure\n\nUltrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.'}], 'classes': [{'title': 'L2-3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'L3-4', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'L4-5', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately prior to spinal anesthesia', 'description': 'The actual vertebral interspace that the anesthesia provider marked \\& identified, as verified by ultrasound.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Level of Conus Medullaris - Sitting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spinal Anesthesia', 'description': 'Infants receiving spinal anesthesia for standard of care procedure\n\nUltrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.'}], 'classes': [{'title': 'T12-L1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'L1-2', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'L2-3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'L3-4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Unable to obtain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately prior to spinal anesthesia', 'description': 'Assessing the level of the conus medullaris by ultrasound in the sitting position.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Mark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spinal Anesthesia', 'description': 'Infants receiving spinal anesthesia for standard of care procedure\n\nUltrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately prior to spinal anesthesia', 'description': 'The amount of time if took for the anesthesia provider to manually palpate and mark the desired interspace.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Conduct Ultrasound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spinal Anesthesia', 'description': 'Infants receiving spinal anesthesia for standard of care procedure\n\nUltrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '63.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately prior to spinal anesthesia', 'description': 'The amount of time it took for the investigator to identify the actual space that the provider marked using ultrasound.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spinal Anesthesia', 'description': 'Infants receiving spinal anesthesia for standard of care procedure\n\nUltrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Spinal Anesthesia', 'description': 'Infants receiving spinal anesthesia for standard of care procedure\n\nUltrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'BG000', 'lowerLimit': '63.5', 'upperLimit': '70.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'BG000', 'lowerLimit': '6.8', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'American Society of Anesthesiologists (ASA) status', 'classes': [{'title': 'ASA I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': 'ASA II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'ASA III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The ASA score is a subjective assessment of a patient's overall health that is based on five classes (I to V):\n\nI = Patient is a completely healthy fit patient. II = Patient has mild systemic disease. III = Patient has severe systemic disease that is not incapacitating. IV = Patient has incapacitating disease that is a constant threat to life. V = A moribund patient who is not expected to live 24 hours with or without surgery.", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-08', 'size': 351064, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-16T13:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2021-02-12', 'resultsFirstSubmitDate': '2022-08-18', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-18', 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intended Interspace', 'timeFrame': 'Immediately prior to spinal anesthesia', 'description': 'The vertebral interspace that the anesthesia provider believes that they had marked \\& identified by manual palpation'}, {'measure': "Actual Interspace of Provider's Mark", 'timeFrame': 'Immediately prior to spinal anesthesia', 'description': 'The actual vertebral interspace that the anesthesia provider marked \\& identified, as verified by ultrasound.'}], 'secondaryOutcomes': [{'measure': 'Level of Conus Medullaris - Sitting', 'timeFrame': 'Immediately prior to spinal anesthesia', 'description': 'Assessing the level of the conus medullaris by ultrasound in the sitting position.'}, {'measure': 'Time to Mark', 'timeFrame': 'Immediately prior to spinal anesthesia', 'description': 'The amount of time if took for the anesthesia provider to manually palpate and mark the desired interspace.'}, {'measure': 'Time to Conduct Ultrasound', 'timeFrame': 'Immediately prior to spinal anesthesia', 'description': 'The amount of time it took for the investigator to identify the actual space that the provider marked using ultrasound.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anesthesia, Local', 'Infant Conditions']}, 'descriptionModule': {'briefSummary': 'Although the current standard for lumbar puncture and spinal anesthesia is the use of manual palpation of surface landmarks to identify the correct interspace, performance of the procedure at too high of a level may increase the incidence of adverse effects. The current study will evaluate the efficacy of ultrasound in identifying the correct intervertebral space for lumbar puncture thereby improving the safety of the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients less than 1 year of age scheduled for spinal anesthesia for elective lower abdominal, urologic, or lower extremity surgery at Nationwide Children's Hospital\n\nExclusion Criteria:\n\n* Parents unwilling for their children to undergo spinal anesthesia for surgery.\n* Children with known spinal anomalies including sacral dimple.\n* Children with coagulation abnormalities or receiving anticoagulation which precludes the use of spinal anesthesia.\n* Children with superficial or deep infections over the spine which precludes the use of spinal anesthesia."}, 'identificationModule': {'nctId': 'NCT04757805', 'briefTitle': 'Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Assessment of the Accuracy of the Manual Palpation of Surface Landmarks Versus Ultrasound for Identification of the Correct Intervertebral Space for Spinal Anesthesia in Children Less Than 1 Year of Age', 'orgStudyIdInfo': {'id': 'STUDY00000558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spinal anesthesia', 'description': 'Infants receiving spinal anesthesia for standard of care procedure', 'interventionNames': ['Diagnostic Test: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.', 'armGroupLabels': ['Spinal anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical Anesthesiology and Pain Medicine', 'investigatorFullName': 'Giorgio Veneziano', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}