ClinicalTrials.gg
Active, not recruitingNCT06310499DROWN_CODUpdated Aug 27, 2025

Primary or Secondary Drowning

An observational study in Drowning, Drowning; Anoxia and Drowning, Near, sponsored by Prehospital Center, Region Zealand. Active, not recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by Prehospital Center, Region Zealand · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
700
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Drowning
  • Drowning; Anoxia
  • Drowning, Near
  • Drowning in Swimming Pool
  • Drowning; Asphyxia
  • Drowning/Diving/SCUBA Accident
  • Drowning or Immersion of Unknown Intent
  • Drowning and Submersion, Undetermined Intent
  • Drowning and Submersion While in Bath-Tub
  • Drowning and Submersion While in Natural Water
  • Drowning and Submersion Due to Sailboat Sinking
  • Drowning and Submersion Due to Fall Off Ship
  • Drowning and Submersion While in Swimming-Pool

Keywords

  • Drowning
  • Epidemiology
  • Danish Prehospital Drowning Data
  • Danish Drowning Formula
  • Registry
  • Cohort
  • Autopsy
  • Cause of death
  • Death certificate
  • Database
  • Denmark
  • Utstein
03

In context

Drowning

21 studies on the registry are indexed under Drowning; 6 are open to participants now.

This study's planned enrollment of 700 is below the median of 1,099 across 14 observational studies indexed under Drowning.

Browse Drowning studies →

Lead sponsor

Prehospital Center, Region Zealand is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
700 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherDrowning

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

06

What researchers measure

Primary outcomes

  1. Autopsy rate

    Calculated as the number of autopsy reports divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.

    Time frame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.

  2. 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.

    Time frame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.

  3. 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.

    Time frame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 37619443 ↗
  • 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. PubMed 21775346 ↗
  • Breindahl N, Bitzer K, Sorensen OB, Wildenschild A, Wolthers SA, Lindskou T, Steinmetz J, Blomberg SNF, Christensen HC; Danish Drowning Validation Group. The Danish Drowning Cohort: Utstein-style data from fatal and non-fatal drowning incidents in Denmark. BMC Med Res Methodol. 2025 Jan 30;25(1):28. doi: 10.1186/s12874-025-02483-8. PubMed 39885431 ↗

Individual participant data

Plan to share: No — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2016 (actual). Primary completion is estimated for Dec 2025, 119 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2024
First posted
Mar 15, 2024
StartActual
Jan 1, 2016
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2026
Last update
Aug 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06310499
Lead sponsor
Prehospital Center, Region Zealand
Responsible party
Niklas Breindahl (Principal Investigator, Prehospital Center, Region Zealand) — Principal investigator
First posted
Mar 15, 2024
Start date
Jan 1, 2016
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 27, 2025

Study contacts

Helle Collatz Christensen, Ass. Prof.
study director · Prehospital Center, Region Zealand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion