Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-01 @ 6:16 PM
Study NCT ID:
NCT03671902
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2018-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-21', 'studyFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the phonocardiographic systolic index (PSI)', 'timeFrame': 'Baseline, and at each incremental change of 5-10 mmHg up to 40 mm Hg. Total duration per arm is up to 45 min', 'description': 'Measuring changes in phonocardiographic parameters related to changes in blood volume'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phonocardiogram'], 'conditions': ['Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The goal of these studies is to assess the use of phonocardiograhy to monitor blood volume. We will evaluate phonocardiographic parameters in normal subjects in increasing levels of lower body negative pressure (LBNP) and lower body positive pressure (LBPP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old\n* Good health\n* Free of systemic diseases\n* No contraindications to LBNP/LBPP exposure\n* Normal resting systolic blood pressure (SBP, 100-140 mm Hg) and diastolic blood pressure (DBP, 60-90 mm Hg)\n\nExclusion Criteria:\n\n* Pregnancy\n* Prior history of cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT03671902', 'briefTitle': 'Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests', 'orgStudyIdInfo': {'id': 'STUDY00030287 DF18055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lower Body Negative/Positive Pressure', 'interventionNames': ['Device: Fluid shift']}], 'interventions': [{'name': 'Fluid shift', 'type': 'DEVICE', 'description': 'We are using lower body negative and positive pressure to create a fluid shift in the body. This study is investigating if there are changes in phonocardiographic parameters related to changes in blood volume caused by this fluid shift', 'armGroupLabels': ['Lower Body Negative/Positive Pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Jay C. Buckey, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'James C. Leiter', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}