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CompletedNCT02681731Updated Mar 15, 2018

Impact of Neuromonitoring During Cardiac Procedures

An observational study in Delirium, Stroke and Acute Kidney Injury, sponsored by Medtronic - MITG. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-15.

Sponsored by Medtronic - MITG · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
250,000
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Delirium
  • Stroke
  • Acute Kidney Injury

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03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 250,000 is above the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

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Lead sponsor

Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

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

Exclusion Criteria:

  • \<18 years of age
  • Cardiac procedures not requiring cardiopulmonary bypass
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
250,000 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 years

  2. 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

    Time frame: 5 years

  3. Stroke: Incidence of stroke identified by ICD-9 diagnosis code

    Incidence of stroke identified by ICD-9 diagnosis code

    Time frame: 5 years

07

Study locations

1 site
  • Vanderbilt University School of Medicine
    Nashville, Tennessee 37212, United States
08

References and documents

Individual participant data

Plan to share: No — There is no individual participant data in this retrospective database study.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02681731
Lead sponsor
Medtronic - MITG
Responsible party
Sponsor
First posted
Feb 12, 2016
Start date
Mar 2016
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Mar 15, 2018

Study contacts

Andrew Shaw, MB FRCA
principal investigator · Vanderbilt University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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