- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05184972
Coverage and Validity of the Swedish Registry of Cardiopulmonary Resuscitation Regarding In-hospital Cardiac Arrest
September 6, 2023 updated by: Jennie Silverplats, Dalarna University
The study will have an observational retrospective cross-sectional design.
Patient records and hospital administrative systems at 10 hospitals in Sweden will be searched using ICD-codes to find all patients treated for an in-hospital cardiac arrest (IHCA) during the time period of 20180101 to 20191231.
All found patients will be cross-checked against reported patients in the Swedish Registry of Cardiopulmonary Resuscitation (SRCR).
Any differences in patient characteristics or regarding situation factors between reported and non-reported patients will be evaluated.
Non-reported patients will be retrospectively reported to the registry.
An incidence of IHCA will be calculated using the number of patients treated for IHCA divided by number of hospital admissions during the specific time period.
Selected variables will be evaluated regarding compliance to report and regarding concordance with patient records.
All missing data will be described and evaluated.
Local reporting procedures at each hospital will be described and evaluated regarding compliance to report and regarding missing data.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1109
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gothenburg, Sweden
- Registercentrum Västra Götaland
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 weeks and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
An in-hospital cardiac arrest is defined as an arrest that occurs in a hospitalized patient who had a pulse at the time of admission.
A hospital is defined as a facility with twenty-four hours a day care including an intensive care unit and an emergency team.
Treatment of a cardiac arrest involves initiation of CPR or defibrillation.
Data of patients treated for in-hospital cardiac arrest will be collected from 10 hospitals of varying size during 20180101 to 20191231 in Sweden.
Data of reported patients treated for in-hospital cardiac arrest during the same time period at each hospital will be extracted from the SRCR .
Description
Inclusion Criteria:
- All patients after the neonatal period that have been treated for an in-hospital cardiac arrest.
Exclusion Criteria:
- Patients with an in-hospital cardiac arrest that is not treated (do not attempt resuscitation) or patients in the neonatal period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Non-reported patients treated for in-hospital cardiac arrest
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Reported patients treated for in-hospital cardiac arrest
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of reported patients treated for in-hospital cardiac arrest
Time Frame: During hospital stay (retrospective observation january 1 2018 to december 31 2019)
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To evaluate the proportion of patients treated for in-hospital cardiac arrest that are reported to the SRCR
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During hospital stay (retrospective observation january 1 2018 to december 31 2019)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of in-hospital cardiac arrest
Time Frame: During hospital stay (retrospective observation january 1 2018 to december 31 2019)
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To calculate an incidence of number of patients treated for in-hospital cardiac arrest based on number of hospital admissions during a specific time period.
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During hospital stay (retrospective observation january 1 2018 to december 31 2019)
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Patient characteristics
Time Frame: During hospital stay (retrospective observation january 1 2018 to december 31 2019)
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To evaluate possible differences in patient characteristics or situation factors between reported and non-reported patients treated for in-hospital cardiac arrest.
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During hospital stay (retrospective observation january 1 2018 to december 31 2019)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reporting procedures at hospitals
Time Frame: At study start (interview with CPR coordinators)
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To describe reporting procedures at each hospital in relation to coverage of patients treated for in-hospital cardiac arrest.
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At study start (interview with CPR coordinators)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anneli Strömsöe, PhD, Dalarna University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2022
Primary Completion (Actual)
June 12, 2023
Study Completion (Actual)
September 6, 2023
Study Registration Dates
First Submitted
December 8, 2021
First Submitted That Met QC Criteria
December 22, 2021
First Posted (Actual)
January 11, 2022
Study Record Updates
Last Update Posted (Actual)
September 7, 2023
Last Update Submitted That Met QC Criteria
September 6, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-04102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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