Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-28 @ 6:38 PM
Study NCT ID:
NCT00654693
Status:
COMPLETED
Last Update Posted:
2012-09-07
First Post:
2008-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NTX Wireless Patient Monitoring System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057209', 'term': 'Hospital Rapid Response Team'}], 'ancestors': [{'id': 'D010348', 'term': 'Patient Care Team'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-06', 'studyFirstSubmitDate': '2008-04-03', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of patient compliance with wearing device', 'timeFrame': '24 hour minimum post op'}], 'secondaryOutcomes': [{'measure': 'Determine accuracy of the NTX wireless monitoring system', 'timeFrame': 'duration of patient involvement'}, {'measure': 'Determine false alarm rates', 'timeFrame': 'duration of patient involvement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NTX', 'Nihon Kohden', 'mobile monitoring', 'monitoring', 'nihon', 'kohden', 'monitoring device', 'remote monitoring', 'wireless'], 'conditions': ['Desaturation', 'Bradycardia', 'Tachycardia', 'Hypertension', 'Hypotension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.vandydreamteam.com', 'label': 'Vanderbilt University Medical Center Department of Anesthesiology'}]}, 'descriptionModule': {'briefSummary': '* Determine the accuracy of the NTX wireless monitoring system alerts\n* Evaluate patient compliance with wearing device\n* Determine false alarm rates', 'detailedDescription': "Approximately 150 patients will have wireless monitors attached to their arm. They will have their vital signs filtered through software that generates alerts and records data. The alert engine will produce pager and application based pop-up alerts which will be sent to the research nurse. Low and high limit alarms will be set according to the published guidelines (Hillman, K. et. Al., Resuscitation 48(2): 105-10, 2001) and adjusted at will by the response team.\n\nDuring this portion of the study, the following research related procedures will be performed:\n\n* begin continuous vital signs monitoring (BP - 1x per hour, 3 lead ECG -continuous, HR - continuous, SpO2 - continuous)\n* PI or Co-PI will review each alert that's generated. The clinical significance will be determined and recorded in the study database\n* Record patient's signs and symptoms daily\n* Assess concomitant\n* Assess AE's, SAEs"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited in the Vanderbilt University Medical Center pre-operative clinic or in the Round Wing, after the effects of anesthesia have worn off. Before performing any trial-related procedures, written Informed Consent and HIPAA authorization will be obtained.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to give written informed consent\n* Patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the Vanderbilt University Medical Center Round Wing\n* Patients must be ≥18 years of age\n\nExclusion Criteria:\n\n* ICU patients\n* Female subjects who are pregnant\n* Patients \\< 18 years of age\n* Patients that have a contradiction for continuous Blood Pressure monitoring'}, 'identificationModule': {'nctId': 'NCT00654693', 'briefTitle': 'NTX Wireless Patient Monitoring System', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': "A Pilot Study to Evaluate the Performance of Nihon Kohden's NTX Wireless Patient Monitoring System", 'orgStudyIdInfo': {'id': '080021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'monitored', 'description': 'patients hospitalized for longer than 24 hours and are located on the 4th, 5th, and 6th floors of the Vanderbilt University Medical Center Round Wing', 'interventionNames': ['Other: Rapid Response Team']}], 'interventions': [{'name': 'Rapid Response Team', 'type': 'OTHER', 'otherNames': ['- attending nurse action per VUMC protocol'], 'description': 'If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.', 'armGroupLabels': ['monitored']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'James M Berry, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'James Berry', 'investigatorAffiliation': 'Vanderbilt University'}}}}