Clinical trial NCT02400892: Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
Official title: Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foramen Ovale, Patent
Delirium
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will involve adult patients planned to undergo an elective, primary hip or knee replacement surgery at one of the hospitals of the London Health Sciences Centre (University Hospital or Victoria Hospital).

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.


Eligibility 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

Primary outcomes:
measure: Postoperative delirium - measured by Confusion Assessment Method (CAM) Scores positive for delirium
timeFrame: Daily CAM assessment starting Postoperative Day #1 after surgery until discharge or up to 1 week postoperatively
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Postoperative length of hospital stay after surgery( expected mean of 4 days)
measure: Major adverse events (including Heart Attack, Stroke, Heart failure, Blood clots, Abnormal heart rhythms, other major complications, and death)
timeFrame: Postoperative period until hospital discharge (expected mean of 4 days)
Other outcomes:
Locations:
city: London
country: Canada
facility: University Hospital
state: Ontario
Study officials:
affiliation: Western University
name: Daniel Bainbridge, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gai N, Lavi R, Jones PM, Lee H, Naudie D, Bainbridge D. The use of point-of-care ultrasound to diagnose patent foramen ovale in elective hip and knee arthroplasty patients and its association with postoperative delirium. Can J Anaesth. 2018 Jun;65(6):619-626. doi: 10.1007/s12630-018-1073-7. Epub 2018 Jan 24.