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DrowningNCT05425537

Drowning in Denmark: A Registry-based Study of Fatal and Non-fatal Drowning From 2016 to 2023

An observational study of Drowning, run by Prehospital Center, Region Zealand at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Using nationwide data from the prehospital electronic health records from 2016 to 2023, this registry-based cohort study aims to establish a nationwide epidemiological profile of non-fatal and fatal drowning patients in Denmark in adherence with the Utstein Style For Drowning (USFD) recommended guidelines for uniform… Read more about this study

Who is it for?
Any age
Conditions the study is for
Drowning
What is being tested?
Drowning incident
How many people
1,664 participants
Where
1 siteDenmark
Study dates
1 Jan 2016to 1 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All drowning patients who have been treated by the Danish prehospital emergency medical services in the period from 2016-2023.

Who may be able to join

  • The patient must have been experiencing respiratory impairment from submersion or immersion in liquid AND
  • The patient must have been in contact with the Danish prehospital emergency medical services.

Who cannot join

  • Patients were excluded if the incident involved submersion or immersion with aspiration, but the patient did not experience respiratory impairment. For example, if the patient was rescued from the water without signs of respiratory impairment, or if the respondent reported "a few coughs" or "voluntary cough".

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Prehospital Center

    Næstved, Region Sjælland, 4700

Other trials in Denmark

About this study

Official title: The Epidemiological Profile of Non-fatal and Fatal Drowning: A Danish Nationwide Registry-based Cohort Study

Using nationwide data from the prehospital electronic health records from 2016 to 2023, this registry-based cohort study aims to establish a nationwide epidemiological profile of non-fatal and fatal drowning patients in Denmark in adherence with the Utstein Style For Drowning (USFD) recommended guidelines for uniform reporting of data from drowning. This includes reporting the annual incidence rates per 100,000 person-years, assessing the associations between predefined prognostic variables and 30-day survival, and reporting the spatial distribution of drowning incidents presented on a map of Denmark.

Read the detailed description

Purpose

The purpose of this study is to establish a nationwide epidemiological profile of non-fatal and fatal drowning patients in Denmark which can be used to target educational, preventative, rescue, or treatment strategies to reduce the number of fatal and non-fatal drowning incidents in Denmark.

Objectives

The primary objective is to estimate the yearly incidence rates of drowning patients in Denmark treated by the Danish Emergency Medical Services from 2016 to 2023. The secondary objective is to report the associations between predefined prognostic variables and 30-day survival.

Study design

A nationwide registry-based study with data from the Danish Drowning Cohort (extracted from the prehospital electronic health records using syndromic surveillance and extensive manual validation) from 2016 to 2023 with 30-day follow-up.

Conditions
Drowning
Being tested
Drowning incident
Keywords
Drowning, Non-fatal, Utstein, Register study, Retrospective, Reigstry-based study
Medical subject headings
Drowning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drowning incidentOther

    Drowning is defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid"

Study groups in NCT05425537
Study groupRoleWhat they receive
Fatal drowningFatal drowning incident where the patient died because of the drowning process
Receives: Other: Drowning incident
Non-fatal drowningNon-fatal drowning incident where the patient was drowning and can be ascertained to have been experiencing either mild, moderate, or severe respiratory impairment immediately after the drowning process ended but survived.
Receives: Other: Drowning incident

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annual drowning incidence rates per 100,000 person-years from 2016-2023

    The primary objective is to estimate the annual incidence of fatal and non-fatal drowning patients in Denmark treated by the prehospital emergency medical services from 2016 to 2023 and will be reported as the annual number of cases per 100,000 person-years.

    Measured: Counts of fatal and non-fatal drowning incidents will be obtained between 2016-2023.

  2. 30-day survival following drowning incidents in Denmark from 2016-2023

    The primary outcome is 30-day survival (alive/dead).

    Measured: 30-day follow-up after the drowning incident

Secondary outcomes (2)

  1. Association between prognostic variables and 30-day survival

    This outcome will explore predefined prognostic variables associated with 30-day survival after a drowning incident. The following risk factors will be analysed using multivariable logistic regression models and presented as odds ratios (ORs) with 95% confidence intervals (CIs): witnessed status, sex, age, OHCA, submersion duration, season, location.

    Measured: From 2016-2023

  2. Map of fatal and non-fatal drowning incidents in Denmark from 2016-2023

    Showing a map of geographical localization of drowning in Denmark in the study period indicating 30-day mortality and survival

    Measured: From 2016-2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start1 Jan 2016
  3. Primary completion31 Mar 2023
  4. Study completion1 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,664 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425537
Sponsor's protocol ID
DROWN_NONFATAL
Status last verified
Apr 2025
First submitted
29 May 2022
Last updated
4 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Weiss J; American Academy of Pediatrics Committee on Injury, Violence, and Poison Prevention. Prevention of drowning. Pediatrics. 2010 Jul;126(1):e253-62. doi: 10.1542/peds.2010-1265. Epub 2010 May 24.

    PubMed 20498167

  • Schmidt AC, Sempsrott JR, Szpilman D, Queiroga AC, Davison MS, Zeigler RJ, McAlister SJ. The use of non-uniform drowning terminology: a follow-up study. Scand J Trauma Resusc Emerg Med. 2017 Jul 17;25(1):72. doi: 10.1186/s13049-017-0405-x.

    PubMed 28716063

  • Papa L, Hoelle R, Idris A. Systematic review of definitions for drowning incidents. Resuscitation. 2005 Jun;65(3):255-64. doi: 10.1016/j.resuscitation.2004.11.030.

    PubMed 15919561

  • Lu TH, Lunetta P, Walker S. Quality of cause-of-death reporting using ICD-10 drowning codes: a descriptive study of 69 countries. BMC Med Res Methodol. 2010 Apr 8;10:30. doi: 10.1186/1471-2288-10-30.

    PubMed 20374660

  • Steensberg J. Epidemiology of accidental drowning in Denmark 1989-1993. Accid Anal Prev. 1998 Nov;30(6):755-62. doi: 10.1016/s0001-4575(98)00028-1.

    PubMed 9805518

  • Mackie IJ. Patterns of drowning in Australia, 1992-1997. Med J Aust. 1999 Dec 6-20;171(11-12):587-90. doi: 10.5694/j.1326-5377.1999.tb123808.x.

    PubMed 10721338

  • Truhlar A, Deakin CD, Soar J, Khalifa GE, Alfonzo A, Bierens JJ, Brattebo G, Brugger H, Dunning J, Hunyadi-Anticevic S, Koster RW, Lockey DJ, Lott C, Paal P, Perkins GD, Sandroni C, Thies KC, Zideman DA, Nolan JP; Cardiac arrest in special circumstances section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 4. Cardiac arrest in special circumstances. Resuscitation. 2015 Oct;95:148-201. doi: 10.1016/j.resuscitation.2015.07.017. Epub 2015 Oct 15. No abstract available.

    PubMed 26477412

  • Venema AM, Groothoff JW, Bierens JJ. The role of bystanders during rescue and resuscitation of drowning victims. Resuscitation. 2010 Apr;81(4):434-9. doi: 10.1016/j.resuscitation.2010.01.005. Epub 2010 Feb 10.

    PubMed 20149515

  • Idris AH, Berg RA, Bierens J, Bossaert L, Branche CM, Gabrielli A, Graves SA, Handley AJ, Hoelle R, Morley PT, Papa L, Pepe PE, Quan L, Szpilman D, Wigginton JG, Modell JH; American Heart Association. Recommended guidelines for uniform reporting of data from drowning: the "Utstein style". Circulation. 2003 Nov 18;108(20):2565-74. doi: 10.1161/01.CIR.0000099581.70012.68. No abstract available.

    PubMed 14623794

Questions about this trial

What is this clinical trial studying?

An observational study of Drowning, run by Prehospital Center, Region Zealand at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annual drowning incidence rates per 100,000 person-years from 2016-2023 (time frame: Counts of fatal and non-fatal drowning incidents will be obtained between 2016-2023.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05425537, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.

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