Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-01-04 @ 9:52 PM
Study NCT ID:
NCT05166993
Status:
COMPLETED
Last Update Posted:
2022-01-12
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Electronic Filter for Arterial Waveform Distortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2018-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-22', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The present study was aimed to test the MostCareUp electronic filter', 'timeFrame': '15 minutes', 'description': 'To test the electronic filter comparing the electronically corrected arterial pressure and the derived cardiac output values with those corrected with the Accudynamic, a mechanical adjustable damping device commonly used in clinical practice.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Underdamping/Resonance Artifacts']}, 'descriptionModule': {'briefSummary': 'Invasive blood pressure (IBP) is the gold standard for arterial pressure (AP) monitoring in critically ill patients. Nevertheless, IBP may be affected by underdamping/resonance artifacts, that eventually lead to AP overestimation. In these cases, when a pulse contour method is applied, wrong hemodynamic data are also delivered by the monitor. In order to overtake this issue, MostCareUp (a PCM powered by Pressure Recording Analytical Method, PRAM), has been implemented with a dynamic electronic filter (EFMC) that automatically corrects the resonant AP waveform.\n\nIn order to test the EFMC, the electronically corrected AP and the derived cardiac output were compared with respective raw data corrected with the Accudynamic, an adjustable damping device specifically manufactured for normalizing the pressure waveform (in our study: the reference method).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to postoperative intensive care unit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- ICU patients with invasive blood pressure (radial artery) affected by underdamping/resonance artifacts;\n\nExclusion Criteria:\n\n\\- Arrhythmias'}, 'identificationModule': {'nctId': 'NCT05166993', 'briefTitle': 'Dynamic Electronic Filter for Arterial Waveform Distortion', 'organization': {'class': 'OTHER', 'fullName': 'University of Florence'}, 'officialTitle': 'Arterial Pressure Waveform Distortion: a New Dynamic Electronic Filter for Automatic Correction of Underdamping/Resonance Artifact. A Prospective Study', 'orgStudyIdInfo': {'id': '10285'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MostCareUp', 'type': 'DEVICE', 'description': 'Pressure transducers have been connected to the MostCareUp and the hemodynamic parameters compared as follows: no filter, electronic filter, no electronic filter plus Accudynamic (our reference system). Invasive pressure values have been then compared with the non-invasive ones.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'overallOfficials': [{'name': 'Stefano Romagnoli, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florence'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florence', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gianluca Villa', 'investigatorAffiliation': 'University of Florence'}}}}