Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries

• Register: ClinicalTrials.gov
• Last refreshed on: 19 September 2016
• Main ID: NCT02400892
• Date of registration: 24/03/2015
• Prospective Registration: No
• Primary sponsor: Lawson Health Research Institute
• Public title: Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
• Scientific title: Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
• Date of first enrolment: March 2015
• Target sample size: 226
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02400892
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Daniel Bainbridge, MD, FRCPC
• Affiliation: Western University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Planned to undergo an elective, primary hip replacement surgery or knee replacement
surgery

- Fluent in English

Exclusion Criteria:

- Planned to undergo a revision knee or hip replacement

- History of cardiac surgery or prosthetic heart valves

- History of other structural heart abnormalities, not involving the atrial septum

- 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

- Significant visual problems felt by investigators to impair Confusion Assessment
Method use

- Significant hearing problems felt by investigators to impair Confusion Assessment
Method use

- History of psychiatric problems requiring treatment with major antidepressant drugs
or antipsychotic drugs

- History of a Deep Venous Thrombosis or Pulmonary Embolism in the past year

- History of known Atrial Fibrillation in the past 3 months

- Presence of a pacemaker or implantable cardioverter-defibrillator

- History of Transient Ischemic Attack or Stroke within the past year



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Foramen Ovale, Patent

Arthroplasty, Replacement, Hip

Delirium

Arthroplasty, Replacement, Knee

Intervention(s)

Other: TTE Bubble Study

Primary Outcome(s)

Postoperative delirium - measured by Confusion Assessment Method (CAM) Scores positive for delirium [Time Frame: Daily CAM assessment starting Postoperative Day #1 after surgery until discharge or up to 1 week postoperatively]

Secondary Outcome(s)

Major adverse events (including Heart Attack, Stroke, Heart failure, Blood clots, Abnormal heart rhythms, other major complications, and death) [Time Frame: Postoperative period until hospital discharge (expected mean of 4 days)]

Length of hospital stay [Time Frame: Postoperative length of hospital stay after surgery( expected mean of 4 days)]

Secondary ID(s)

105952

Source(s) of Monetary Support

Please refer to primary and secondary sponsors