Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-01 @ 7:50 PM
Study NCT ID:
NCT03121794
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2017-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographic Identification of the Proximal Humerus Landmarks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-01', 'size': 653936, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-11T18:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2017-03-23', 'studyFirstSubmitQcDate': '2017-04-17', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of proximal humerus landmarks successfully identified by ultrasound exam', 'timeFrame': 'Through completion of ultrasonographic exam, an average of 30 minutes.', 'description': 'Two investigators will perform an ultrasonographic exam on each patient, with one investigator examining each side of the body. Each investigator will aim to identify 6 anatomical landmarks:\n\n1. The humeral shaft,\n2. The surgical neck of the humerus,\n3. The lesser tubercle,\n4. The greater tubercle,\n5. The intertubercular sulcus\n6. The target site in the greater tubercle for needle insertion. Each side will receive a score ranging from 0 to 6 corresponding to the number of landmarks correctly identified.'}], 'secondaryOutcomes': [{'measure': 'Time used to identify all 6 anatomical landmarks using ultrasound in seconds.', 'timeFrame': 'Through completion of ultrasonographic exam, an average of 30 minutes.', 'description': 'Evaluate the time used to identify all 6 anatomical landmarks using ultrasound.'}, {'measure': 'Depth of each landmark from the skin in centimeters.', 'timeFrame': 'Through completion of ultrasonographic exam, an average of 30 minutes.', 'description': 'Depth of each landmark from the skin in centimeters based on ultrasound measurements.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasonography', 'Intraosseous Vascular access', 'humerus', 'anatomic landmark'], 'conditions': ['Proximal Humerus Interosseous Venous Access', 'Anatomic Landmark', 'Ultrasonography']}, 'descriptionModule': {'briefSummary': 'Evaluate whether discrete landmarks of the proximal humerus can be identified using ultrasound in patients with various body habitus and BMI.', 'detailedDescription': 'There are three main forms of vascular access: peripheral intravenous (PIV), Central venous (CV) and intraosseous (IO). Of the different types of vascular access PIV and CV access have drawbacks when used during resuscitation, because they can be difficult to obtain when patients are volume depleted as in cases of trauma. Attempting CV access has numerous risks with complications occurring in up to 33% of attempts. These include failed placement (22%), arterial puncture (5%), catheter malposition (4%), pneumothorax (1%) and asystolic cardiac arrest (\\<1%). Attempting to obtain CV access may also disrupt chest compressions in cases of cardiac arrest. Intraosseous access has been used in scenarios where PIV and CV access is difficult or impossible to obtain. Pharmacokinetic studies and standard practice support the bioequivalence of intraosseous and intravenous administration of common medications. Intravascular depletion does not hinder attempts at IO access, and as the insertion sites are peripheral to the heart, insertion can be done avoiding interruptions in chest compressions. Obtaining proximal humerus interosseous (PHIO) access may also be faster than obtaining both PIV and CV access with a relatively low complication rate. In one survey, complications of IO included difficulty in identifying correct anatomical site (3%), extravasation (3.7%), displacement after insertion (8.5%), and very rarely late complications including compartment syndrome (0.6%), osteomyelitis (0.4%) and skin infection (0.3%).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be selected after chart review of current patients undergoing general, cardiac, thoracic, or vascular surgery. Patients will be approached in the preoperative clinic or during their hospitalization (preoperatively or postoperatively). Informed consent will be obtained prior to performing the study.\n\nParticipants will be separated into 3 cohorts based on BMI. The number of participants in each cohort is as follows: 10 patients with BMI 18.5 - 25 kg/m2; 10 patients with BMI 30-35 kg/m2, 10 patients with BMI \\> 40 kg/m2.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females 18 years of age or older undergoing general, cardiac, thoracic or vascular surgery.\n* BMI \\>= 18.5 kg/m\\^2\n\nExclusion Criteria:\n\n* Limited mobility/ range of motion of arms\n* Prior surgical intervention on shoulder or humerus\n* History of arm dislocation with internal rotation\n* History of arm fracture\n* BMI in ranges: 25.1 - 29.9, 35.1 - 39.9'}, 'identificationModule': {'nctId': 'NCT03121794', 'briefTitle': 'Ultrasonographic Identification of the Proximal Humerus Landmarks', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Ultrasonographic Identification of the Proximal Humerus Landmarks for Intra-Osseous Vascular Access Across Different Body Habitus', 'orgStudyIdInfo': {'id': '16-1642'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low BMI', 'description': 'Ultrasonographic identification of proximal humerus landmarks for patients with BMI 18.5 - 25 kg/m2', 'interventionNames': ['Procedure: Ultrasonographic exam', 'Device: ultrasound machine']}, {'label': 'Moderate BMI', 'description': 'Ultrasonographic identification of proximal humerus landmarks for patients with BMI 30-35 kg/m2 will receive ultrasound exam.', 'interventionNames': ['Procedure: Ultrasonographic exam', 'Device: ultrasound machine']}, {'label': 'High BMI', 'description': 'Ultrasonographic identification of proximal humerus landmarks for patients with BMI \\> 40 kg/m2 will receive ultrasound exam.', 'interventionNames': ['Procedure: Ultrasonographic exam', 'Device: ultrasound machine']}], 'interventions': [{'name': 'Ultrasonographic exam', 'type': 'PROCEDURE', 'description': 'The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks', 'armGroupLabels': ['High BMI', 'Low BMI', 'Moderate BMI']}, {'name': 'ultrasound machine', 'type': 'DEVICE', 'description': 'Regular ultrasound machine used at Cleveland Clinic', 'armGroupLabels': ['High BMI', 'Low BMI', 'Moderate BMI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'SergioB17', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}