Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-20 @ 7:37 AM
Study NCT ID:
NCT06895603
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoints', 'timeFrame': 'Approximately 8 months for accrual and follow-up', 'description': 'The comparison of cardiac output between the Philips AMC and PAC'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['ICU', 'Surgical Patients']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare cardiac output (CO), fluid responsiveness, and related measurements between the Philips AMC and PAC (Swan-Ganz) in ICU or surgical patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 75 ICU patients being monitored with a PAC and radial arterial line will be enrolled over approximately 8 months accrual and follow-up evaluation period', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Indication for PAC (Swan-Ganz)\n* Indication for radial arterial line\n* Subject or legal authorized representative is able to understand and speak the local language (also Spanish is also accepted for US sites) to provide voluntary written informed consent prior to study procedures\n\nExclusion Criteria:\n\n* Emergency surgery\n* ICU or surgical positioning where both arms are tucked\n* Inability to place the Philips AMC appropriately due to subject anatomy or condition\n* Known pregnancy or lactating women (self-report)\n* Patients treated with an intra-aortic balloon pump\n* Measurements taken in the lateral position\n* Currently participating in an investigational drug or another device study that clinically interferes with the study endpoints\n* Upper arm circumference \\< 19 cm or \\> 43 cm\n* BMI \\> 45\n* At the PI's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above"}, 'identificationModule': {'nctId': 'NCT06895603', 'acronym': 'CO', 'briefTitle': 'The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)', 'orgStudyIdInfo': {'id': 'HIPULSE-CO_PAC_2021_11366'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All patients being monitored with a pulmonary artery catheter', 'description': 'Up to 75 intensive care unit patients being monitored with a pulmonary artery catheter (approximately 20 patients from at least 2 sites during the roll-in phase and approximately 55 patients during the pivotal phase) will be enrolled over an estimated 8 months accrual and follow-up evaluation period. There will be no randomization in this study.', 'interventionNames': ['Device: Philips Advanced Monitoring Cuff (AMC)']}], 'interventions': [{'name': 'Philips Advanced Monitoring Cuff (AMC)', 'type': 'DEVICE', 'description': 'The Philips AMC is a Class II (USA) and Class IIb (EU) medical device that is a non-invasive, semirigid disposable upper arm cuff with an integrated pneumatic actuator enabling hydraulic coupling of tissue pressure waveforms from the upper arm tissue.', 'armGroupLabels': ['All patients being monitored with a pulmonary artery catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22904', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UVA Health', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Lea Egger', 'role': 'CONTACT', 'email': 'lea.egger@philips.com', 'phone': '+49 172 2314 318'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}