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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02400892
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel Bainbridge, 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.

Condition or disease Intervention/treatment
Foramen Ovale, Patent Delirium Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee Other: TTE Bubble Study

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Study Type : Observational
Actual Enrollment : 226 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
Study Start Date : March 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Length of hospital stay [ Time Frame: Postoperative length of hospital stay after surgery( expected mean of 4 days) ]
  2. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400892


Locations
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Canada, Ontario
University Hospital
London, Ontario, Canada, N6G 2V4
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Daniel Bainbridge, MD, FRCPC Western University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Bainbridge, Associate Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02400892    
Other Study ID Numbers: 105952
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Delirium
Foramen Ovale, Patent
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities