Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-02-06 @ 11:18 PM
Study NCT ID:
NCT05470335
Status:
RECRUITING
Last Update Posted:
2024-08-06
First Post:
2022-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurse-led Sheath Insertion in Cardiac Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2022-05-31', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain level', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'pain level during sheath insertion is measured using a 1 to 10 point numeric rating scale. For pain registration: 0 is no pain and 10 the worst imaginable pain.'}, {'measure': 'comfort level', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'comfort level during sheath insertion is measured using a 1 to 10 point numeric rating scale. For comfort: 0 is no comfort at all and 10 is the best imaginable comfort.'}], 'secondaryOutcomes': [{'measure': 'success rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'success rate with regard to successful sheath insertion is assured'}, {'measure': 'time consumption', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'time consumption for both groups'}, {'measure': 'convertion', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'successful conversion yes/no from physician to nurse or from nurse to physician determined by the possibility to accomplish the diagnostic or therapeutic procedure'}, {'measure': 'complications', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'occurrence of radial occlusion, perforation, pseudoaneurysm, and compartment syndrome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The aim of project NUSHI is to elucidate, that radial sheath insertion can be performed by nurses and physicians with the same level of comfort and safety.', 'detailedDescription': 'Background: Insertion of sheath in the radial artery in connection with examination and treatment of patients with coronary artery disease is usually performed by specialized invasive cardiologists or trainees. Whether sheath insertion can be performed by nurses with the same level of comfort and pain is uncertain.\n\nEligibility: Patients referred for coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) due to suspicion of coronary artery disease are included\n\nRandomization: Patients are randomized 1:1 to sheath insertion by nurse or physician\n\nMethods: Insertion of 5 or 6 radial sheaths is performed in local anesthesia\n\nOutcome measures: Comfort and pain level is registered from immediately after sheath insertion until start of CAG/PCI.\n\nAdditional outcome measures: Oximetry test is performed immediately after sheath removal - and repeated after 1 month in case of occlusion. Any complication is recorded from the patient enters the wake-up room until discharge.\n\nAll patients are contacted after 1 year in order to register adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients suspected of having coronary artery disease\n* with normal puls oxymetry on the right hand\n* understands patient information and accepts to participate\n\nExclusion Criteria:\n\n* under consideration for cardiac valve replacement\n* systolic blood pressure persistently \\>180 mmHg'}, 'identificationModule': {'nctId': 'NCT05470335', 'acronym': 'NUSHI', 'briefTitle': 'Nurse-led Sheath Insertion in Cardiac Patients', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Patient Comfort, Success Rate, Procedure Time and Complications During Sheath Insertion by Nurses and Physicians in Connection With Invasive Examination and Treatment of Cardiac Patients', 'orgStudyIdInfo': {'id': 'EMN-2021-08143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'physician insertion', 'description': 'radial sheath insertion is performed by physicians'}, {'type': 'EXPERIMENTAL', 'label': 'nurse insertion', 'description': 'radial sheath insertion is performed by nurses', 'interventionNames': ['Procedure: nurse-led sheath insertion']}], 'interventions': [{'name': 'nurse-led sheath insertion', 'type': 'PROCEDURE', 'description': 'radial sheaths for coronary examination and intervention are performed by experienced nurses', 'armGroupLabels': ['nurse insertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK 4000', 'city': 'Roskilde', 'state': 'Danmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Henning Kelbaek', 'role': 'CONTACT', 'email': 'heke@regionsjaelland.dkdadlnet.dk', 'phone': '20230078'}, {'name': 'Connie Olsen', 'role': 'CONTACT', 'email': 'clo@reionsjaelland.dk', 'phone': '47326169'}, {'name': 'Yama Fakhri, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zealand University Hospital', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'centralContacts': [{'name': 'Henning Kelbaek, MD', 'role': 'CONTACT', 'email': 'heke@regionsjaelland.dk', 'phone': '20230078'}, {'name': 'Connie Olsen, RN', 'role': 'CONTACT', 'email': 'clo@regionsjaelland.dk', 'phone': '47326169'}], 'overallOfficials': [{'name': 'Henning Kelbæk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}