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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02400892
Enrollment
226
Registered
2015-03-27
Start date
2015-03-31
Completion date
2016-06-30
Last updated
2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERTTE Bubble Study

Bedside transthoracic echocardiogram bubble study to assess for the presence or absence of a PFO

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Postoperative delirium - measured by Confusion Assessment Method (CAM) Scores positive for deliriumDaily CAM assessment starting Postoperative Day #1 after surgery until discharge or up to 1 week postoperatively

Secondary

MeasureTime frame
Length of hospital stayPostoperative 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)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026