Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT04490369
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2020-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab
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': 175}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2020-07-24', 'studyFirstSubmitQcDate': '2020-07-24', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total medication administration dosage as measured by the procedural database', 'timeFrame': 'During procedure, up to 2.5 hours'}, {'measure': 'Frequency of medication administration as measured by the procedural database', 'timeFrame': 'During procedure, up to 2.5 hours'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS)', 'timeFrame': 'Within 2 hours of procedure'}, {'measure': 'Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT)', 'timeFrame': 'During procedure, to 2.5 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Procedural sedation', 'Cardiac Catheterization'], 'conditions': ['Patient Comfort']}, 'referencesModule': {'references': [{'pmid': '36640418', 'type': 'RESULT', 'citation': 'Mall A, Girton TA, Yardley K, Ronn M, Cross E, Smith PJ, Rossman P, McEwen T, Ohman EM, Jones WS, Granger BB. Timing of sedation and patient-reported pain outcomes during cardiac catheterization: Results from the UNTAP-intervention study. Catheter Cardiovasc Interv. 2023 Jan 14. doi: 10.1002/ccd.30535. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore how the timing of procedural sedation medications influences patient comfort and satisfaction with sedation.\n\nParticipation in this study will included be randomly assigned to one of two groups (long and short) within standard of care. Each group will observe a time interval between receiving procedural sedation medications and the start of the procedure. A trained observer will evaluate patient experience during the procedure and at the end of the procedure we will ask the participant 3 brief questions about the experience. All other information collected about the experience during the procedure will occur as part of usual care. No further activities will be asked as part of this study. All study activities will occur during a scheduled visit and participation is complete once questions have been answered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients coming to Duke University for Cardiac Catheterization', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking\n* Coming to Duke University for Cardiac Catheterization\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04490369', 'briefTitle': 'Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab', 'orgStudyIdInfo': {'id': 'Pro00102686'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1- short interval', 'description': 'Less than or equal to six minutes between receiving sedation and the start of the procedure'}, {'label': 'Group 2- long interval', 'description': 'Greater than or equal to seven minutes between receiving sedation and the start of the procedure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Bradi Granger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}