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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400892
• Other study ID #: 105952
• Status: Completed
• Phase: N/A
• First received: March 24, 2015
• Last updated: September 6, 2016
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• TTE Bubble Study
Bedside transthoracic echocardiogram bubble study to assess for the presence or absence of a PFO

Locations

Country	Name	City	State
Canada	University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Length of hospital stay		Postoperative length of hospital stay after surgery( expected mean of 4 days)	No
Secondary	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)	Yes