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

Lawson Health Research Institute

Status: Completed

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

Treatments: Other: TTE Bubble Study

Study type: Observational

Funder types: Other

Identifiers

NCT02400892

105952

Details and patient eligibility

About

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.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

226 participants in 2 patient groups

PFO

Description:

Subjects with a bedside Transthoracic Echocardiogram (TTE) bubble study positive for a PFO

Treatment:

Other: TTE Bubble Study

Control

Description:

Subjects with a bedside TTE bubble study negative for a PFO

Treatment:

Other: TTE Bubble Study