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Impact of Neuromonitoring During Cardiac Procedures

Impact of Neuromonitoring During Cardiothoracic Procedures: A Retrospective Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02681731
Enrollment
250000
Registered
2016-02-12
Start date
2016-03-31
Completion date
2017-12-31
Last updated
2018-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Delirium, Stroke

Brief summary

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.

Detailed description

The purpose of this study is to mine the Premier Healthcare Database to: 1. define the incidence of post-operative cognitive complications, acute kidney injury and stroke after specific cardiac surgical procedures (defined as: coronary artery bypass graft \[CABG\], Aortic Valve Replacement, Mitral valve repair, Mitral valve replacement, thoracic aortic operation, combined CABG and Valve replacement or repair ; and 2. Determine the incremental increase in the length of hospitalization and cost of hospitalization among cardiac surgical patients who suffer postoperative cognitive complications, acute kidney injury and stroke; and 3. Determine the effectiveness of intraoperative neuromonitoring with cerebral saturation and/or processed electroencephalogram (EEG) monitoring on the incidence of post-operative cognitive complications, acute kidney injury and stroke as a consequence of specific cardiac surgery procedures. The Premier Healthcare Database is a privately owned database that represents approximately 1/5th of all United States hospitalizations annually. It includes all International Classification of Diseases-9th Revision (ICD-9) and International Classification of Diseases-Clinical Modification (ICD-9-CM) diagnosis and procedure codes recorded by the hospital, as well as a limited set of Current Procedural Terminology (CPT)-4 codes. Within the database, discharge-level data include information on patient and provider characteristics, diagnoses and procedures, hospital resource utilization, and charges/cost data for all entries, including pharmacy charges.

Interventions

None listed

Sponsors

Medtronic - MITG
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Delirium: Incidence of post-operative cognitive complications identified by ICD-9 diagnosis code5 yearsIncidence of post-operative cognitive complications identified by International Classification of Disease (ICD-9) diagnosis code
Acute Kidney Injury: Incidence of acute kidney injury identified by ICD-9 diagnosis code5 yearsIncidence of acute kidney injury identified by ICD-9 diagnosis code
Stroke: Incidence of stroke identified by ICD-9 diagnosis code5 yearsIncidence of stroke identified by ICD-9 diagnosis code

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026