---
title: Impact of Neuromonitoring During Cardiac Procedures
nct_id: NCT02681731
overall_status: COMPLETED
sponsor: Medtronic - MITG
study_type: OBSERVATIONAL
primary_condition: Delirium
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02681731.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02681731"
ct_last_update_post_date: 2018-03-15
last_seen_at: "2026-05-12T06:24:43.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Impact of Neuromonitoring During Cardiac Procedures

**Official Title:** Impact of Neuromonitoring During Cardiothoracic Procedures: A Retrospective Analysis

**NCT ID:** [NCT02681731](https://clinicaltrials.gov/study/NCT02681731)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 250000
- **Lead Sponsor:** Medtronic - MITG
- **Conditions:** Delirium, Stroke, Acute Kidney Injury
- **Start Date:** 2016-03
- **Completion Date:** 2017-12-31
- **CT.gov Last Update:** 2018-03-15

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 100 Years
- **Sex:** ALL
- **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
```

## 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

## Locations (1)

- Vanderbilt University School of Medicine, Nashville, Tennessee, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.vanderbilt university school of medicine|nashville|tennessee|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02681731.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02681731*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*