Clinical trial NCT05425537: Drowning in Denmark: A Registry-based Study of Fatal and Non-fatal Drowning From 2016 to 2023
Official title: The Epidemiological Profile of Non-fatal and Fatal Drowning: A Danish Nationwide Registry-based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drowning
Keywords: Drowning
Non-fatal
Utstein
Register study
Retrospective
Reigstry-based study
Lead sponsor: Prehospital Center, Region Zealand
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 1664
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All drowning patients who have been treated by the Danish prehospital emergency medical services in the period from 2016-2023.

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.

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.

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

- 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".

Primary outcomes:
measure: Annual drowning incidence rates per 100,000 person-years from 2016-2023
timeFrame: Counts of fatal and non-fatal drowning incidents will be obtained between 2016-2023.
measure: 30-day survival following drowning incidents in Denmark from 2016-2023
timeFrame: 30-day follow-up after the drowning incident
Secondary outcomes:
measure: Association between prognostic variables and 30-day survival
timeFrame: From 2016-2023
measure: Map of fatal and non-fatal drowning incidents in Denmark from 2016-2023
timeFrame: From 2016-2023
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Prehospital Center
state: Region Zealand
Study officials:
affiliation: Prehospital Center, Region Zealand
name: Niklas Breindahl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.