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

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.

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Key information

Conditions

Foramen Ovale, Patent Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee Cardiovascular Abnormalities Cardiovascular Diseases Confusion Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Delirium Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

London, Ontario, N6G 2V4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TTE Bubble Study

Other

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

Primary outcomes

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

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Mar 27, 2015
Registry last updated: Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed