The National Early Warning Score: Preceding Dynamics in the Score for Those Who Suffer an In-hospital Cardiac Arrest
NCT ID: NCT03143062
Last Updated: 2018-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
381 participants
OBSERVATIONAL
2017-09-30
2018-09-02
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Cases
150 patients that suffered an in-hospital cardiac arrest in a hospital ward.
NEWS
NEWS
Controls
300 patients that did not suffer an in-hospital cardiac arrest but was treated in a hospital ward.
NEWS
NEWS
Interventions
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NEWS
NEWS
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Karin Samuelson, Ass Professor
Role: PRINCIPAL_INVESTIGATOR
Region Skåne
Locations
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Region Skåne
Kristianstad, , Sweden
Countries
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Other Identifiers
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RegionSkaneKrYHVOAnIVAMS2
Identifier Type: -
Identifier Source: org_study_id
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