Clinical trial NCT03143062: The National Early Warning Score: Preceding Dynamics in the Score for Those Who Suffer an In-hospital Cardiac Arrest
Official title: The National Early Warning Score: Preceding Dynamics in the Score for Those Who Suffer an In-hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rapid Response System
Vital Signs
Keywords: National Early Warning Score
Rapid response system
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in hospital wards

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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:

-

Primary outcomes:
measure: Dynamics in the National Early Warning Score (NEWS) in the 24 hours preceding an in-hospital cardiac arrest.
timeFrame: 24 hours preceding an in-hospital cardiac arrest
Secondary outcomes:
Other outcomes:
Locations:
city: Kristianstad
country: Sweden
facility: Region Skåne
Study officials:
affiliation: Region Skåne
name: Karin Samuelson, Ass Professor
role: PRINCIPAL_INVESTIGATOR
References: