- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05425537
Drowning in Denmark: A Registry-based Study of Fatal and Non-fatal Drowning From 2016 to 2023
The Epidemiological Profile of Non-fatal and Fatal Drowning: A Danish Nationwide Registry-based Cohort Study
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Region Zealand
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Næstved, Region Zealand, Denmark, 4700
- Prehospital Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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".
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Fatal drowning
Fatal drowning incident where the patient died because of the drowning process
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Drowning is defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid"
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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.
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Drowning is defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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.
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Counts of fatal and non-fatal drowning incidents will be obtained between 2016-2023.
|
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30-day survival following drowning incidents in Denmark from 2016-2023
Time Frame: 30-day follow-up after the drowning incident
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The primary outcome is 30-day survival (alive/dead).
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30-day follow-up after the drowning incident
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between prognostic variables and 30-day survival
Time Frame: From 2016-2023
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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.
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From 2016-2023
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Map of fatal and non-fatal drowning incidents in Denmark from 2016-2023
Time Frame: From 2016-2023
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Showing a map of geographical localization of drowning in Denmark in the study period indicating 30-day mortality and survival
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From 2016-2023
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Collaborators and Investigators
Investigators
- Principal Investigator: Niklas Breindahl, MD, PhD, Prehospital Center, Region Zealand
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DROWN_NONFATAL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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