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

Study Overview
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Brief Summary
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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.

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

Conditions
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Foramen Ovale, Patent, Delirium, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Other: TTE Bubble Study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PFO<br>Subjects with a bedside Transthoracic Echocardiogram (TTE) bubble study positive for a PFO | Other: TTE Bubble Study<br>* Bedside transthoracic echocardiogram bubble study to assess for the presence or absence of a PFO<br>|
| Control<br>Subjects with a bedside TTE bubble study negative for a PFO | Other: TTE Bubble Study<br>* Bedside transthoracic echocardiogram bubble study to assess for the presence or absence of a PFO<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | Postoperative length of hospital stay after surgery( expected mean of 4 days) | 
| Major adverse events (including Heart Attack, Stroke, Heart failure, Blood clots, Abnormal heart rhythms, other major complications, and death) |  | Postoperative period until hospital discharge (expected mean of 4 days) |