NCT06310499

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2016Dec 2026

Study Start

First participant enrolled

January 1, 2016

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

10 years

First QC Date

March 7, 2024

Last Update Submit

August 20, 2025

Conditions

Keywords

DrowningEpidemiologyDanish Prehospital Drowning DataDanish Drowning FormulaRegistryCohortAutopsyCause of deathDeath certificateDatabaseDenmarkUtstein

Outcome Measures

Primary Outcomes (3)

  • Autopsy rate

    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

    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

    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.

Study Arms (2)

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

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

Interventions

Drowning is defined as the process of experiencing respiratory impairment from submersion or immersion in liquid.

Primary fatal drowningSecondary fatal drowning

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prehospital Center

Næstved, Region Sjælland, 4700, Denmark

Location

Related Publications (2)

  • Breindahl N, Wolthers SA, Jensen TW, Holgersen MG, Blomberg SNF, Steinmetz J, Christensen HC; Danish Cardiac Arrest Group. Danish Drowning Formula for identification of out-of-hospital cardiac arrest from drowning. Am J Emerg Med. 2023 Nov;73:55-62. doi: 10.1016/j.ajem.2023.08.024. Epub 2023 Aug 15.

    PMID: 37619443BACKGROUND
  • Helweg-Larsen K. The Danish Register of Causes of Death. Scand J Public Health. 2011 Jul;39(7 Suppl):26-9. doi: 10.1177/1403494811399958.

    PMID: 21775346BACKGROUND

MeSH Terms

Conditions

DrowningHypoxiaNear DrowningAsphyxia

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Helle Collatz Christensen, Ass. Prof.

    Prehospital Center, Region Zealand

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 15, 2024

Study Start

January 1, 2016

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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.

Locations