Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-03 @ 11:10 PM
Study NCT ID:
NCT02400892
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2015-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054092', 'term': 'Foramen Ovale, Patent'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative delirium - measured by Confusion Assessment Method (CAM) Scores positive for delirium', 'timeFrame': 'Daily CAM assessment starting Postoperative Day #1 after surgery until discharge or up to 1 week postoperatively'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Postoperative length of hospital stay after surgery( expected mean of 4 days)'}, {'measure': 'Major adverse events (including Heart Attack, Stroke, Heart failure, Blood clots, Abnormal heart rhythms, other major complications, and death)', 'timeFrame': 'Postoperative period until hospital discharge (expected mean of 4 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Foramen Ovale, Patent', 'Delirium', 'Arthroplasty, Replacement, Hip', 'Arthroplasty, Replacement, Knee']}, 'referencesModule': {'references': [{'pmid': '29368313', 'type': 'DERIVED', 'citation': 'Gai N, Lavi R, Jones PM, Lee H, Naudie D, Bainbridge D. The use of point-of-care ultrasound to diagnose patent foramen ovale in elective hip and knee arthroplasty patients and its association with postoperative delirium. Can J Anaesth. 2018 Jun;65(6):619-626. doi: 10.1007/s12630-018-1073-7. Epub 2018 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'This study will involve patients who are planned to have hip or knee replacement surgeries. They will undergo a Transthoracic Echocardiogram study (an ultrasound of the heart) to look for a Patent Foramen Ovale (PFO). A PFO is a hole in the heart that everyone is born with and in most cases eventually closes by adulthood. However, it does not always close in all people. The investigators will compare the participants as two groups - those with a PFO, and those without, and look for differences in delirium in their postoperative stay. This will help us look for an association between postoperative delirium and the presence of a PFO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will involve adult patients planned to undergo an elective, primary hip or knee replacement surgery at one of the hospitals of the London Health Sciences Centre (University Hospital or Victoria Hospital).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Planned to undergo an elective, primary hip replacement surgery or knee replacement surgery\n* Fluent in English\n\nExclusion Criteria:\n\n* Planned to undergo a revision knee or hip replacement\n* History of cardiac surgery or prosthetic heart valves\n* History of other structural heart abnormalities, not involving the atrial septum\n* History of preexisting neurologic condition that affects the patient's day-to-day life, including a history of Dementia, Stroke, or previous Neurosurgery causing ongoing problems\n* Significant visual problems felt by investigators to impair Confusion Assessment Method use\n* Significant hearing problems felt by investigators to impair Confusion Assessment Method use\n* History of psychiatric problems requiring treatment with major antidepressant drugs or antipsychotic drugs\n* History of a Deep Venous Thrombosis or Pulmonary Embolism in the past year\n* History of known Atrial Fibrillation in the past 3 months\n* Presence of a pacemaker or implantable cardioverter-defibrillator\n* History of Transient Ischemic Attack or Stroke within the past year"}, 'identificationModule': {'nctId': 'NCT02400892', 'briefTitle': 'Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries', 'orgStudyIdInfo': {'id': '105952'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PFO', 'description': 'Subjects with a bedside Transthoracic Echocardiogram (TTE) bubble study positive for a PFO', 'interventionNames': ['Other: TTE Bubble Study']}, {'label': 'Control', 'description': 'Subjects with a bedside TTE bubble study negative for a PFO', 'interventionNames': ['Other: TTE Bubble Study']}], 'interventions': [{'name': 'TTE Bubble Study', 'type': 'OTHER', 'description': 'Bedside transthoracic echocardiogram bubble study to assess for the presence or absence of a PFO', 'armGroupLabels': ['Control', 'PFO']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6G 2V4', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Daniel Bainbridge, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniel Bainbridge', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}