Impact of Neuromonitoring During Cardiac Procedures

Stroke Clinical Trial

Official title:

Impact of Neuromonitoring During Cardiothoracic Procedures: A Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681731
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: February 10, 2016
• Last updated: March 13, 2018
• Start date: March 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Delirium
• Stroke

Locations

Country	Name	City	State
United States	Vanderbilt University School of Medicine	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

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