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The National Early Warning Score: Preceding Dynamics in the Score for Those Who Suffer an In-hospital Cardiac Arrest

2018年9月3日 更新者:Region Skane

To this date no clinical evaluation reports of the dynamics in the National Early Warning Score (NEWS) for those patients who suffer an in-hospital cardiac arrest, IHCA, exists. This process needs to be investigated in order to optimize the future care of these patients.

Research Questions H1: Patients that suffer an IHCA has had higher NEWS in the preceding 24 hours from the event compared to those who did not suffer an IHCA.

H2: The dynamics in the NEWS, differs between the patients that suffer an IHCA and those who do not in the preceding 24 hours from the event.

研究概览

地位

完全的

干预/治疗

详细说明

Power:

A sample size of 300 patients in the control group and 150 patients in the group that suffered from an IHCA would generate a power estimate of 80 percent if the difference in the median is one point on the NEWS with a standard deviate of three points.

Analysis of the Research Data:

Categorical and nonparametric data will be presented in median (25-75 percentiles).

A hypothesis testing will be performed where the documented NEWS will be categorized into low-, medium- and high-risk and divided into different timespans. The timespans will be 0-6 h, 6-12 h, 12-18 and 18-24 h preceding the IHCA. In case of multiple NEWS measurements within each timespan, the worst NEWS measurement will be chosen. Each timespan during the 24 hours will not be treated as repeated measures and will be tested by the Chi square test. This test is chosen because the data is categorical. Another hypothesis test where all the NEWS measurements will be included and each documented NEWS on the same patient will be treated as repeated measures. A binary logistic regression analysis will be performed using Generalized Estimating Equations (GEE) and modelled to fit.

In order to select the covariates that is to be included in the regression analysis a non-parametric test including all the parameters in the NEWS will be executed. The level of significance for this test will be set to p=0.2 2. Collinearity within the NEWS parameters that is to be included in the regression analysis will be tested. The level of collinearity that is accepted will be <+0,6 and >-0,6. A binomial logistic regression analysis will be executed with the selected parameters in the NEWS The outcome of the regression analysis will be presented as odds ratio (OR).

研究类型

观察性的

注册 (实际的)

381

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Kristianstad、瑞典
        • Region Skane

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients in hospital wards

描述

Inclusion Criteria:

All patients ≥18 years of age admitted to the hospitals during a period of 12 months will be reviewed for eligibility

Exclusion Criteria:

-

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Cases
150 patients that suffered an in-hospital cardiac arrest in a hospital ward.
NEWS
Controls
300 patients that did not suffer an in-hospital cardiac arrest but was treated in a hospital ward.
NEWS

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Dynamics in the National Early Warning Score (NEWS) in the 24 hours preceding an in-hospital cardiac arrest.
大体时间:24 hours preceding an in-hospital cardiac arrest
All documented National Early Warning Scores (NEWS) on eligible patients admitted to a hospital ward will be collected. The NEWS will be divided into different timespans in the 24 hours preceding the in-hospital cardiac arrest. A control group of patients will also have their NEWS collected. The NEWS of the control group and the cases will then be entered into the hypothesis testing. The aim is to find some dynamics in the NEWS that separates the patients that suffers an in-hospital cardiac arrest from those who do not in the 24 hours preceding the event.
24 hours preceding an in-hospital cardiac arrest

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Karin Samuelson, Ass Professor、Region Skane

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年9月30日

初级完成 (实际的)

2018年9月2日

研究完成 (实际的)

2018年9月2日

研究注册日期

首次提交

2017年4月24日

首先提交符合 QC 标准的

2017年5月3日

首次发布 (实际的)

2017年5月8日

研究记录更新

最后更新发布 (实际的)

2018年9月5日

上次提交的符合 QC 标准的更新

2018年9月3日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • RegionSkaneKrYHVOAnIVAMS2

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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NEWS的临床试验

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