Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT00750958
Status:
COMPLETED
Last Update Posted:
2008-09-11
First Post:
2008-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-10', 'studyFirstSubmitDate': '2008-09-10', 'studyFirstSubmitQcDate': '2008-09-10', 'lastUpdatePostDateStruct': {'date': '2008-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of clinically significant rhythm and rate changes in ED patients.', 'timeFrame': 'Patient ED stay'}], 'secondaryOutcomes': [{'measure': 'Measure of user-friendliness of the device.', 'timeFrame': 'Patient ED stay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiac rhythm changes'], 'conditions': ['Cardiac Event']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the incidence of clinically significant rhythm and rate changes in ED patients who are not placed on conventional telemetry, and to test the user-friendliness of a automated clinician alter device in hectic and noisy setting of a busy emergency room.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 yes\n* Agree to participate in study\n* Telemetry not indicated\n* Telemetry not available\n* Willingness to complete a questionnaire-\n\nExclusion Criteria:\n\n* Refusal to participate\n* Know sensitivity to adhesive\n* Language/communication barriers\n* Perceived high risk for lack of study compliance'}, 'identificationModule': {'nctId': 'NCT00750958', 'acronym': 'PREVENT', 'briefTitle': 'PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard', 'organization': {'class': 'INDUSTRY', 'fullName': 'Datascope Patient Monitoring'}, 'officialTitle': 'PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard', 'orgStudyIdInfo': {'id': '807119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'ED patients that are not monitored with conventional therapy.', 'interventionNames': ['Procedure: NetGuard Automated Clinician Alert System']}], 'interventions': [{'name': 'NetGuard Automated Clinician Alert System', 'type': 'PROCEDURE', 'otherNames': ['NetGurard Automated Clinican Alert Systemm'], 'description': 'Monitoring System for in-hospital patients who are typically unmonitored. Identifies and alarms for cardiac rhythm changes.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Dr Charles Pollack', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Charles Pollack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennslvania Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Datascope Patient Monitoring', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Charles Pollack, Jr.', 'oldOrganization': 'Pennsylvania Hospital'}}}}