Clinical Trial: Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
Brief Summary: 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.
Detailed Summary:
Sponsor: Lawson Health Research Institute
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Length of hospital stay [ Time Frame: 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) [ Time Frame: Postoperative period until hospital discharge (expected mean of 4 days) ]
Original Secondary Outcome: Same as current
Information By: Lawson Health Research Institute
Dates:
Date Received: March 24, 2015
Date Started: March 2015
Date Completion:
Last Updated: September 6, 2016
Last Verified: September 2016
