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

Completed

• Conditions: Delirium; Arthroplasty, Replacement, Knee; Foramen Ovale, Patent; Arthroplasty, Replacement, Hip
• Interventions: Other: TTE Bubble Study

• Registration Number: NCT02400892
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• Planned to undergo an elective, primary hip replacement surgery or knee replacement surgery
• Fluent in English

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PFO	TTE Bubble Study	Subjects with a bedside Transthoracic Echocardiogram (TTE) bubble study positive for a PFO
Control	TTE Bubble Study	Subjects with a bedside TTE bubble study negative for a PFO

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University Hospital; 🇨🇦 London, Ontario, Canada