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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Sweden
      • Gothenburg, Sweden
        • Registercentrum Västra Götaland

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Non-reported patients treated for in-hospital cardiac arrest
Reported patients treated for in-hospital cardiac arrest

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
To evaluate the proportion of patients treated for in-hospital cardiac arrest that are reported to the SRCR
During hospital stay (retrospective observation january 1 2018 to december 31 2019)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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.
During hospital stay (retrospective observation january 1 2018 to december 31 2019)
Patient characteristics
Time Frame: During hospital stay (retrospective observation january 1 2018 to december 31 2019)
To evaluate possible differences in patient characteristics or situation factors between reported and non-reported patients treated for in-hospital cardiac arrest.
During hospital stay (retrospective observation january 1 2018 to december 31 2019)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reporting procedures at hospitals
Time Frame: At study start (interview with CPR coordinators)
To describe reporting procedures at each hospital in relation to coverage of patients treated for in-hospital cardiac arrest.
At study start (interview with CPR coordinators)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dalarna University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dalarna County Council, Sweden

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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