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

NCT02400892 | Completed

• 1 other identifier: 105952
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Study Arms (2)

PFO

Subjects with a bedside Transthoracic Echocardiogram (TTE) bubble study positive for a PFO

Other: TTE Bubble Study

Control

Subjects with a bedside TTE bubble study negative for a PFO

Other: TTE Bubble Study

Interventions

TTE Bubble Study OTHER

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

Control; PFO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University Hospital

London, Ontario, N6G 2V4, Canada

Location

Related Publications (1)

• 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.

  PMID: 29368313 DERIVED

MeSH Terms

Conditions

Foramen Ovale, Patent; Delirium

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Daniel Bainbridge, MD, FRCPC

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

CA (1)