Rapid Response SystemNCT03143062
The National Early Warning Score: Preceding Dynamics in the Score for Those Who Suffer an In-hospital Cardiac Arrest
An observational study of Rapid Response System and Vital Signs, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rapid Response System, Vital Signs
- What is being tested?
- NEWS
- How many people
- 381 participants
- Where
- 1 siteSweden
- Study dates
- 30 Sep 2017to 2 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in hospital wards
Who may be able to join
- All patients ≥18 years of age admitted to the hospitals during a period of 12 months will be reviewed for eligibility
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Rapid Response System, Vital Signs
- Being tested
- NEWS
- Keywords
- National Early Warning Score, Rapid response system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEWSDiagnostic test
NEWS
| Study group | Role | What they receive |
|---|---|---|
| Cases | 150 patients that suffered an in-hospital cardiac arrest in a hospital ward. Receives: Diagnostic Test: NEWS | |
| Controls | 300 patients that did not suffer an in-hospital cardiac arrest but was treated in a hospital ward. Receives: Diagnostic Test: NEWS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamics in the National Early Warning Score (NEWS) in the 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.
Measured: 24 hours preceding an in-hospital cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start30 Sep 2017
- Primary completion2 Sep 2018
- Study completion2 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Response SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin Samuelson, Ass Professor, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143062
- Sponsor's protocol ID
- RegionSkaneKrYHVOAnIVAMS2
- Status last verified
- Sep 2018
- First submitted
- 24 Apr 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Early Warning Score: Preceding Dynamics in the Score for Those Who Suffer an In-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03143062
- Acronym / sponsor ID
- RegionSkaneKrYHVOAnIVAMS2
- Conditions
- Rapid Response System, Vital Signs
- Keywords
- National Early Warning Score, Rapid response system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 2 Sep 2018 (actual)
- Study completion
- 2 Sep 2018 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: NEWS150 patients that suffered an in-hospital cardiac arrest in a hospital ward. |
| Controls | – | Diagnostic Test: NEWS300 patients that did not suffer an in-hospital cardiac arrest but was treated in a hospital ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in hospital wards
Key inclusion criteria (1 listed)
- All patients ≥18 years of age admitted to the hospitals during a period of 12 months will be reviewed for eligibility
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEWSNEWS | Diagnostic test | Cases, Controls |
Primary outcome
Dynamics in the National Early Warning Score (NEWS) in the 24 hours preceding an in-hospital cardiac arrest.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Samuelson, Ass Professor principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rapid Response System and Vital Signs, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamics in the National Early Warning Score (NEWS) in the 24 hours preceding an in-hospital cardiac arrest. (time frame: 24 hours preceding an in-hospital cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.