Stroke Clinical Trial
Official title:
Impact of Neuromonitoring During Cardiothoracic Procedures: A Retrospective Analysis
Verified date | March 2018 |
Source | Medtronic - MITG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Through a series of sequential analyses, retrospective database exploration looking for linkages and associations between the use of processed electroencephalogram (EEG) and/or cerebral saturation monitoring and patient outcomes post-cardiothoracic surgery will be explored.
Status | Completed |
Enrollment | 250000 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - All adult (age >=18 years) hospitalized patients who underwent major cardiac surgical procedure requiring cardiopulmonary bypass captured in the premier database from January 1, 2010 - December 31, 2014 (5 year period) Exclusion Criteria: - <18 years of age - Cardiac procedures not requiring cardiopulmonary bypass |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University School of Medicine | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Medtronic - MITG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delirium: Incidence of post-operative cognitive complications identified by ICD-9 diagnosis code | Incidence of post-operative cognitive complications identified by International Classification of Disease (ICD-9) diagnosis code | 5 years | |
Primary | Acute Kidney Injury: Incidence of acute kidney injury identified by ICD-9 diagnosis code | Incidence of acute kidney injury identified by ICD-9 diagnosis code | 5 years | |
Primary | Stroke: Incidence of stroke identified by ICD-9 diagnosis code | Incidence of stroke identified by ICD-9 diagnosis code | 5 years |
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