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Impact of Neuromonitoring During Cardiac Procedures

Sponsor
Medtronic - MITG (Industry)
Overall Status
Completed
CT.gov ID
NCT02681731
Collaborator
(none)
250,000
Enrollment
1
Location
22
Duration (Months)
11357.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    250000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Impact of Neuromonitoring During Cardiothoracic Procedures: A Retrospective Analysis
    Study Start Date :
    Mar 1, 2016
    Actual Primary Completion Date :
    Dec 31, 2017
    Actual Study Completion Date :
    Dec 31, 2017

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. Stroke: Incidence of stroke identified by ICD-9 diagnosis code [5 years]

      Incidence of stroke identified by ICD-9 diagnosis code

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt University School of Medicine Nashville Tennessee United States 37212

    Sponsors and Collaborators

    • Medtronic - MITG

    Investigators

    • Principal Investigator: Andrew Shaw, MB FRCA, Vanderbilt University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic - MITG
    ClinicalTrials.gov Identifier:
    NCT02681731
    Other Study ID Numbers:
    • 1
    First Posted:
    Feb 12, 2016
    Last Update Posted:
    Mar 15, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Delirium
    Acute Kidney Injury

    Study Results

    No Results Posted as of Mar 15, 2018