Clinical trial NCT02681731: Impact of Neuromonitoring During Cardiac Procedures
Official title: Impact of Neuromonitoring During Cardiothoracic Procedures: A Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Stroke
Acute Kidney Injury
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2016-02-12
Enrollment: 250000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult (age \>=18 years) inpatients who underwent major cardiac surgical procedure requiring cardiopulmonary bypass captured in the Premier database from January 1, 2010 - December 31, 2014 (5 year period).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delirium: Incidence of post-operative cognitive complications identified by ICD-9 diagnosis code
timeFrame: 5 years
measure: Acute Kidney Injury: Incidence of acute kidney injury identified by ICD-9 diagnosis code
timeFrame: 5 years
measure: Stroke: Incidence of stroke identified by ICD-9 diagnosis code
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University School of Medicine
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Andrew Shaw, MB FRCA
role: PRINCIPAL_INVESTIGATOR
References: