Primary or Secondary Drowning (DROWN_COD)

March 13, 2024 updated by: Niklas Breindahl, Prehospital Center, Region Zealand

Primary or Secondary Fatal Drowning? A Registry-based Study Analysing Autopsy Reports From Patients Registered in the Danish Prehospital Drowning Data

According to WHO's rules, any death certificate must state the underlying cause of death and contributory causes of death may also be stated.

Differentiating between primary and secondary drowning is difficult, as information preceding the drowning incident is rarely available. Yet, knowing the most frequent causes of secondary drowning may provide useful information to healthcare professionals working in prehospital Emergency Medical Services, as this may affect prehospital treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The annual death statistics are based solely on the underlying cause of death, that is the disease or condition which started the process that led to death. The conditions that directly caused the death are also to be stated by the physician on the death certificate and may be included in the statistics. In research projects, data on those contributory causes of death may be drawn from the register. It is now the medical doctor who has verified the death and issued the death certificate indicating the underlying and contributory causes of death, who also classifies these causes in accordance with ICD-10 and fills in the coded data on the electronic death certificate. The Danish Register of Causes of Death is, thus, updated without central validation of the classification and relies entirely on the coding done by individual physicians.

This study aims to characterise fatal drowning incidents as primary or secondary drownings and report the frequencies of secondary drowning causes.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Region Zealand
      • Næstved, Region Zealand, Denmark, 4700
        • Prehospital Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The Danish Prehospital Drowning Data reports prehospital data on patients with fatal and non-fatal drowning treated by the Emergency Medical Services in Denmark since 2016. Drowning incidents are identified from the Danish Prehospital Electronic Medical Record using the Danish Drowning Formula and extensive manual validation. Data is extracted following the revised USFD. The patients' unique civil registration number enable linkage with the Civil Personal Register to obtain data on 30-day survival and differentiate between fatal and non-fatal drowning incidents

Description

Inclusion Criteria:

  • All drowning patients registered in the Danish Prehospital Drowning Data AND
  • Having a fatal outcome within 30 days after the drowning incident AND
  • Having a valid civil registration number in the Danish Prehospital Drowning Data
  • Being able to link data from the Danish Register of Causes of Death

Exclusion Criteria:

  • Patients alive 30 days after the drowning incident
  • Patients with an invalid civil registration number in the Danish Prehospital Drowning Data
  • Patients where data cannot be retrieved from the Danish Register of Causes of Death

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
Intervention / Treatment
Primary fatal drowning
These patients are registered in the Danish Register of Causes of Death, with drowning as an underlying cause of death in the death certificate.
Other: Drowning
Drowning is defined as the process of experiencing respiratory impairment from submersion or immersion in liquid.
Secondary fatal drowning
These patients are registered in the Danish Register of Causes of Death, with drowning as a contributory cause of death or drowning not registered in the death certificate.
Other: Drowning
Drowning is defined as the process of experiencing respiratory impairment from submersion or immersion in liquid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autopsy rate
Time Frame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Calculated as the number of autopsy reports divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.
Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Primary fatal drowning rate
Time Frame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Calculated as the number of autopsy reports stating drowning as the underlying cause of death divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.
Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Secondary fatal drowning rate
Time Frame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Calculated as the number of autopsy reports stating drowning as the contributory cause of death OR not stating drowning as a contributory cause of death divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.
Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.

Collaborators and Investigators

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

Sponsor

Prehospital Center, Region Zealand

Investigators

  • Study Director: Helle Collatz Christensen, Ass. Prof., Prehospital Center, Region Zealand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

August 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DROWN_COD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data are available upon reasonable request from researchers after application to the corresponding author, provided the necessary approvals are obtained from the relevant authorities.

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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