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临床试验/NCT03973320
NCT03973320已完成不适用

Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 11,292 人开始时间: 2018年12月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11,292
试验地点
1
主要终点
Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality

研究概览

简要总结

This is a retrospective chart review to determine if neuraxial anesthesia is associated with worse outcomes after Primary Total Hip Arthroplasty.

详细描述

The goal of this study is to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty. The plan to analyze the outcomes is listed below:

Primary outcomes:

Multiple logistic regression will be used to compute the adjusted odds ratios of any postoperative complications (MI, CVA, death) , adjusting for covariates including duration of intraoperative mean arterial pressure of less than pre-defined threshold, such as 55, or 60 mmHg mean blood pressure.

Sensitivity analyses will also consider the effects of intra-operative hypotension (IOH) defined as mean blood pressure of less than 40, 45, 50, 55, 60, and 65 mm Hg.

Secondary outcomes:

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All primary total hip arthroplasty patient data with sufficiently complete intraoperative vital signs

排除标准

  • Revision primary total hip arthroplasty
  • Incomplete intraoperative vital signs
  • Anterior total hip arthroplasty

结局指标

主要结局

Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality

时间窗: Day of Surgery (Day 0) through discharge (days til discharge is an average of 2 days), follow-ups up to 30 days post-surgery

The association between levels and length of intraoperative controlled hypotension and incidence rates of individual and composite outcome of any of the following events: (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death. If any of these events are positive, then the composite outcome will be positive. The units of measurement will be the same.

次要结局

未报告次要终点

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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