Foramen Ovale, PatentNCT02400892
Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
An observational study of Foramen Ovale, Patent and Delirium, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foramen Ovale, Patent, Delirium, Arthroplasty, Replacement, Hip
- What is being tested?
- TTE Bubble Study
- How many people
- 226 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Planned to undergo an elective, primary hip replacement surgery or knee replacement surgery
- Fluent in English
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- TTE Bubble Study
- Medical subject headings
- Foramen Ovale, Patent, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTE Bubble StudyOther
Bedside transthoracic echocardiogram bubble study to assess for the presence or absence of a PFO
| Study group | Role | What they receive |
|---|---|---|
| PFO | Subjects with a bedside Transthoracic Echocardiogram (TTE) bubble study positive for a PFO Receives: Other: TTE Bubble Study | |
| Control | Subjects with a bedside TTE bubble study negative for a PFO Receives: Other: TTE Bubble Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium - measured by Confusion Assessment Method (CAM) Scores positive for delirium
Measured: Daily CAM assessment starting Postoperative Day #1 after surgery until discharge or up to 1 week postoperatively
Secondary outcomes (2)
Length of hospital stay
Measured: 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)
Measured: Postoperative period until hospital discharge (expected mean of 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foramen Ovale, PatentStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Bainbridge, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Daniel Bainbridge, MD, FRCPC, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400892
- Sponsor's protocol ID
- 105952
- Status last verified
- Sep 2016
- First submitted
- 24 Mar 2015
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29368313
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
- ClinicalTrials.gov ID
- NCT02400892
- Acronym / sponsor ID
- 105952
- Conditions
- Foramen Ovale, Patent, Delirium, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFO | – | Other: TTE Bubble StudySubjects with a bedside Transthoracic Echocardiogram (TTE) bubble study positive for a PFO |
| Control | – | Other: TTE Bubble StudySubjects with a bedside TTE bubble study negative for a PFO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Planned to undergo an elective, primary hip replacement surgery or knee replacement surgery
- Fluent in English
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTE Bubble StudyBedside transthoracic echocardiogram bubble study to assess for the presence or absence of a PFO | Other | Control, PFO |
Primary outcome
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
2 secondary outcomes
Length of hospital stay
Time frame: 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)
Time frame: Postoperative period until hospital discharge (expected mean of 4 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Derived from this study: PubMed 29368313Gai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Bainbridge, MD, FRCPC principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foramen Ovale, Patent and Delirium, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02400892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.