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Cerebral Oxygenation and Neurological Functioning After Cardiac Surgery

NCT ID: NCT04081649

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-01

Study Completion Date

2025-06-30

Brief Summary

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The overall goal of this research program is to determine quantitative predictors of quantitative long-term neurological functioning following different cardiac surgery procedures. The investigators aim to generate a timeline of neurological function that includes pre-existing performance, post-operative delirium, and neurological outcome. Furthermore, the investigators will test the hypothesis that intraoperative regional cerebral oxygenation (rSO2) desaturations, as measured by near-infrared spectroscopy (NIRS) are associated with poor neurological functioning following cardiac surgery, as measured by a robotic device called the KINARM.

Detailed Description

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Conditions

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Coronary Artery Disease Cognitive Impairment Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac surgery

Patients undergoing non-emergent cardiac surgery for coronary bypass graft and/or valvular replacement

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* adult patients undergoing coronary artery bypass surgery +/- valvular surgery

Exclusion Criteria

* pre-existing cognitive impairment or neurodegenerative condition
* any reason that participant cannot participate in follow up (lives too far away, limb amputation, speaks language other than english)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Gordon Boyd

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gordon Boyd

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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J. Gordon Boyd, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Kingston General Hospital

Kingston, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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J. Gordon Boyd, MD, PhD

Role: CONTACT

Phone: 6135392754

Email: [email protected]

Facility Contacts

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John G Boyd, MD, PhD

Role: primary

References

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Semrau JS, Scott SH, Hamilton AG, Petsikas D, Payne DM, Bisleri G, Saha T, Boyd JG. Road to recovery: a study protocol quantifying neurological outcome in cardiac surgery patients and the role of cerebral oximetry. BMJ Open. 2019 Dec 3;9(12):e032935. doi: 10.1136/bmjopen-2019-032935.

Reference Type DERIVED
PMID: 31796491 (View on PubMed)

Other Identifiers

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DMED-1672-14

Identifier Type: -

Identifier Source: org_study_id