Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Postoperative delirium - measured by Confusion Assessment Method (CAM) Scores positive for delirium
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned to undergo an elective, primary hip replacement surgery or knee replacement surgery
- •Fluent in English
排除标准
- •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
结局指标
主要结局
Postoperative delirium - measured by Confusion Assessment Method (CAM) Scores positive for delirium
时间窗: Daily CAM assessment starting Postoperative Day #1 after surgery until discharge or up to 1 week postoperatively
次要结局
- 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))
研究者
Daniel Bainbridge
Associate Professor
Lawson Health Research Institute