Impact of Neuromonitoring During Cardiac Procedures

Completed

• Conditions: Stroke; Delirium; Acute Kidney Injury

• Registration Number: NCT02681731
• Lead Sponsor: Medtronic - MITG

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.

Study Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-12
• Study Start: 2016-03
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury: Incidence of acute kidney injury identified by ICD-9 diagnosis code	5 years	Incidence of acute kidney injury identified by ICD-9 diagnosis code
Delirium: Incidence of post-operative cognitive complications identified by ICD-9 diagnosis code	5 years	Incidence of post-operative cognitive complications identified by International Classification of Disease (ICD-9) diagnosis code
Stroke: Incidence of stroke identified by ICD-9 diagnosis code	5 years	Incidence of stroke identified by ICD-9 diagnosis code

Trial Locations

Locations (1)

Vanderbilt University School of Medicine; 🇺🇸 Nashville, Tennessee, United States