Impact of Neuromonitoring During Cardiac Procedures

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delirium Acute Kidney Injury Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Confusion Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Renal Insufficiency Signs and Symptoms Stroke Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University School of Medicine

Nashville, Tennessee, 37212, United States

About this study

The purpose of this study is to mine the Premier Healthcare Database to:

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
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
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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Delirium: Incidence of post-operative cognitive complications identified by ICD-9 diagnosis code

Time frame: 5 years

Incidence 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 code

Time frame: 5 years

Incidence of acute kidney injury identified by ICD-9 diagnosis code
Stroke: Incidence of stroke identified by ICD-9 diagnosis code

Time frame: 5 years

Incidence of stroke identified by ICD-9 diagnosis code

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

Impact of Neuromonitoring During Cardiothoracic Procedures: A Retrospective Analysis

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Feb 12, 2016
Registry last updated: Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed