Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-31 @ 8:34 PM
Study NCT ID:
NCT06439732
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2024-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-05-27', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Anesthetic consumption', 'timeFrame': 'During surgery'}], 'secondaryOutcomes': [{'measure': 'number hypotensive episodes', 'timeFrame': 'during surgery'}, {'measure': 'duration hypotensive episodes', 'timeFrame': 'during surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anestethic comsumption', 'hemodynamic monitoring'], 'conditions': ['Hypotension During Surgery']}, 'descriptionModule': {'briefSummary': 'In this study investigators will study the association between the use of an hemodynamic monitoring system and the anesthetic consumption in patients following major abdominal surgery. Investigators will randomise patients for a control group and an intervention group. Patients belonging to intervention group will be monitored with a non-invasively continue system (Acumen IQ cuff sensor), while the control group will be monitored with a non-invasive intermittent pressure system. The total amount of mL of Sevoflurane will be registered in both groups and the difference will be considered as the aim of our study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years of age\n* signature of informed medical consent\n\nExclusion Criteria:\n\n* BMI\\> 30\n* eGFR\\<30\n* NYHA III-IV\n* severe cardiac valvular diseases\n* absence of informed medical consent'}, 'identificationModule': {'nctId': 'NCT06439732', 'acronym': 'HERMES', 'briefTitle': 'Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery', 'orgStudyIdInfo': {'id': '6704'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'In this group we will use a continuous non-invasive hemodynamic monitoring system (Acumen IQ cuff)', 'interventionNames': ['Device: Acumen IQ cuff']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'In this group we will use the oscillometric non-invasive blood pressure monitoring system'}], 'interventions': [{'name': 'Acumen IQ cuff', 'type': 'DEVICE', 'description': 'Use of Acumen IQ cuff for haemodynamic monitoring', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'Roma', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario "A. Gemelli" IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Andrea Russo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico universitario Agostino Gemelli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'RUSSO ANDREA', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}