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临床试验/NCT02681731
NCT02681731已完成不适用

Impact of Neuromonitoring During Cardiothoracic Procedures: A Retrospective Analysis

Medtronic - MITG1 个研究点 分布在 1 个国家目标入组 250,000 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250,000
试验地点
1
主要终点
Acute Kidney Injury: Incidence of acute kidney injury identified by ICD-9 diagnosis code

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Acute Kidney Injury: Incidence of acute kidney injury identified by ICD-9 diagnosis code

时间窗: 5 years

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

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

时间窗: 5 years

Incidence of post-operative cognitive complications identified by International Classification of Disease (ICD-9) diagnosis code

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

时间窗: 5 years

Incidence of stroke identified by ICD-9 diagnosis code

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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