NCT05425537

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,664

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2016

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

7.2 years

First QC Date

May 29, 2022

Last Update Submit

April 30, 2025

Conditions

Keywords

DrowningNon-fatalUtsteinRegister studyRetrospectiveReigstry-based study

Outcome Measures

Primary Outcomes (2)

  • 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.

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

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

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

    30-day follow-up after the drowning incident

Secondary Outcomes (2)

  • Association between prognostic variables and 30-day survival

    From 2016-2023

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

    From 2016-2023

Study Arms (2)

Fatal drowning

Fatal drowning incident where the patient died because of the drowning process

Other: Drowning incident

Non-fatal drowning

Non-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.

Other: Drowning incident

Interventions

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

Fatal drowningNon-fatal drowning

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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".

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prehospital Center

Næstved, Region Sjælland, 4700, Denmark

Location

Related Publications (9)

  • 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.

    PMID: 20498167BACKGROUND
  • 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.

    PMID: 28716063BACKGROUND
  • 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.

    PMID: 15919561BACKGROUND
  • 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.

    PMID: 20374660BACKGROUND
  • 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.

    PMID: 9805518BACKGROUND
  • 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.

    PMID: 10721338BACKGROUND
  • 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.

    PMID: 26477412BACKGROUND
  • 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.

    PMID: 20149515BACKGROUND
  • 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.

    PMID: 14623794BACKGROUND

MeSH Terms

Conditions

Drowning

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Niklas Breindahl, MD, PhD

    Prehospital Center, Region Zealand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, PhD-student

Study Record Dates

First Submitted

May 29, 2022

First Posted

June 21, 2022

Study Start

January 1, 2016

Primary Completion

March 31, 2023

Study Completion

March 1, 2025

Last Updated

May 4, 2025

Record last verified: 2025-04

Locations