NCT05323097

Brief Summary

Within a six-year period from 2016-2021, this retrospective cohort study aims to: 1) report the national incidence of drowning related OHCA's among cases attended by the Danish Emergency Medical Services (EMS), 2) assess survival defined as return of spontaneous circulation (ROSC) on scene, by hospital admission and 30-day survival. Furthermore, aspects associated with better outcome are evaluated including actions taken by EMS-personnel and laypersons, geographical localization, type of activity, witnessed event, EMS response times, bystander CPR, initial rhythm, use of defibrillator, airway devices, pre-hospital medication, and patient demographics. This can potentially result in recommendations towards certain educative, preventative, rescue, or treatment strategies to reduce OHCA from drowning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31,200

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
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

5.1 years

First QC Date

March 25, 2022

Last Update Submit

March 21, 2024

Conditions

Keywords

DrowningOut-Of-Hospital Cardiac ArrestWaterRegister studyRetrospective

Outcome Measures

Primary Outcomes (1)

  • 30-day survival

    Alive or Dead 30 days after the event.

    30-day after OHCA

Secondary Outcomes (3)

  • Annual incidence and survival rates of drowning-related OHCA per 100,000 from 2016-2021

    Annually from 2016-2021 (at the end of the year)

  • Map of drowning-related OHCA in Denmark from 2016-2021

    5-year period from 2016-2021

  • Survival status at hospital admission

    At hospital admission within 24 hours after admission

Study Arms (2)

Drowning-related OHCA

Drowning-related OHCA: YES

Other: Drowning-related OHCA

All other OHCA

Drowning-related OHCA: NO

Interventions

Drowning-related out-of-hospital cardiac arrest (OHCA): YES

Drowning-related OHCA

Eligibility Criteria

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

All Danish citizens with out-of-hospital cardiac arrest in the period from 2016-2021.

You may qualify if:

  • Out-of-hospital cardiac arrest (OHCA)

You may not qualify if:

  • Obvious clinical signs of irreversible death (decapitation, decomposition, postmortem lividity, postmortem rigidity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prehospital Center

Næstved, Region Sjælland, 4700, Denmark

Location

Related Publications (10)

  • 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
  • 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.

MeSH Terms

Conditions

DrowningOut-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesHeart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Niklas Breindahl, MD

    Prehospital Center, Region Zealand, Denmark

    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

March 25, 2022

First Posted

April 12, 2022

Study Start

January 1, 2016

Primary Completion

January 31, 2021

Study Completion

March 31, 2021

Last Updated

March 25, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

The study protocol and statistical analysis plan are available in Danish from the corresponding author upon request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The study protocol and SAP will be available after publication and up to 5 years after the publication date.
Access Criteria
Upon reasonable request.

Locations