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.

Study Overview

• Status: Completed
• Conditions: Delirium; Arthroplasty, Replacement, Knee; Foramen Ovale, Patent; Arthroplasty, Replacement, Hip
• Intervention / Treatment: Other: TTE Bubble Study

• Study Type: Observational
• Enrollment (Actual): 226

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G 2V4
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PFO; Subjects with a bedside Transthoracic Echocardiogram (TTE) bubble study positive for a PFO	Other: TTE Bubble Study; Bedside transthoracic echocardiogram bubble study to assess for the presence or absence of a PFO
Control; Subjects with a bedside TTE bubble study negative for a PFO	Other: TTE Bubble Study; Bedside transthoracic echocardiogram bubble study to assess for the presence or absence of a PFO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Daniel Bainbridge, MD, FRCPC, Western University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Delirium; Foramen Ovale, Patent
• Other Study ID Numbers: 105952