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Not yet recruitingNCT06312202DROWN_HARBORUpdated Mar 25, 2024

Drowning Incidents in Danish Harbours

An observational study in Drowning, Drown and Drowning; Anoxia, sponsored by Prehospital Center, Region Zealand. Not yet recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2024-03-25.

Sponsored by Prehospital Center, Region Zealand · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Sex
All
01

Study summary

A recent study reported significantly increased mortality from drowning-related out-of-hospital cardiac arrest in Danish harbours compared to other public places (e.g., public pools, coastlines, and lakes). Accurate and reliable data are necessary before establishing specific educational, preventative, rescue, or treatment strategies to reduce the number of drowning incidents in Danish harbours and improve survival. Therefore, it is essential to characterise drowning incidents in Danish harbours and analyse risk factors associated with fatal drowning.

Read the detailed description

Based on the GPS coordinates and advanced text-searching, it is possible to identify drowning incidents in Danish harbours and extract data from the Danish Prehospital Drowning Data.

This study is a nationwide registry-based study with data from the Danish Prehospital Drowning Data from 2016 to 2023. In this study, we will use 30-day mortality to differentiate between fatal and non-fatal drowning.

The primary objective is to estimate the yearly incidence of fatal and non-fatal drowning incidents in Danish harbours treated by the EMS from 2016 to 2023 and calculate the fatal to non-fatal ratio. The secondary objective is to assess risk factors associated with 30-day mortality.

02

Conditions studied

  • Drowning
  • Drown
  • Drowning; Anoxia
  • Drowning, Near
  • Drowning; Asphyxia
  • Drowning and Nonfatal Submersion
  • Drowning or Immersion of Unknown Intent
  • Drowning and Submersion, Undetermined Intent
  • Drowning and Submersion While in Natural Water
  • Drowning and Submersion Due to Sailboat Sinking
  • Drowning and Submersion Due to Fall Off Ship

Keywords

  • Danish Drowning Formula
  • Danish Prehospital Drowning Data
  • Denmark
  • Registry
  • Database
  • Cohort
  • Drowning
  • Harbour
  • Emergency Medical Service
  • Submersion
03

In context

Drowning

21 studies on the registry are indexed under Drowning; 6 are open to participants now.

This study's planned enrollment of 400 is below the median of 1,099 across 14 observational studies indexed under Drowning.

Browse Drowning studies →

Lead sponsor

Prehospital Center, Region Zealand is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The target condition in this study is drowning, irrespective of follow-up at 30 days (fatal or non-fatal). We used the WHO definition of drowning supported by the clarification statement for non-fatal drowning as the case definition to identify drowning (target condition) during the manual validation.

The study unit is the individual drowning patient. The target population are all fatal and non-fatal drowning patients in Danish harbours treated by the EMS in Denmark since 2016. Due to the comprehensive search criteria in the Danish Drowning Formula, it is reasonable to believe that the target population is identical to the study population.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All the patients registered in the Danish Prehospital Drowning Data from 2016-2023 will be assessed for inclusion AND
  • Incidents registered at GPS coordinates corresponding to a Danish harbour OR
  • Incidents identified using advanced text-search algorithm searching for "harbour"-related words

Exclusion criteria

Exclusion Criteria:

  • Patients without a 30-day follow-up (e.g., due to missing or invalid civil registration numbers) and patients with a valid DNAR code will be excluded from the mortality analysis.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Fatal drowning

    This group of patients experienced a drowning incident defined as the process of experiencing respiratory impairment from submersion or immersion in liquid and died within 30 days after the incident as a consequence of the submersion injury.

    Other: Drowning

  • Non-fatal drowning

    This group of patients experienced a drowning incident defined as the process of experiencing respiratory impairment from submersion or immersion in liquid and survived until 30 days after the incident.

    Other: Drowning

Interventions

  • OtherDrowning

    Drowning is defined as the process of experiencing respiratory impairment from submersion or immersion in liquid.

06

What researchers measure

Primary outcomes

  1. Yearly incidence of drowning incidents

    Yearly incidence of fatal and non-fatal drowning incidents in Danish harbours treated by the EMS from 2016-2023

    Time frame: 30 days after the drowning incident

  2. Fatal to non-fatal drowning ratio

    Cumulated counts of fatal to non-fatal drowning incidents from 2016-2023

    Time frame: 30 days after the drowning incident

Secondary outcomes

  1. Assess risk factors associated with 30-day mortality

    Hypothesis-driven assessment of risk factors associated with drowning-related 30-day mortality

    Time frame: 30 days after the drowning incident

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 37619443 ↗

Individual participant data

Plan to share: No — The datasets used and analysed during the current study are available from the corresponding author upon reasonable request.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2024; primary completion for Dec 2024, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2024
First posted
Mar 15, 2024
StartEst.
May 1, 2024
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Mar 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06312202
Lead sponsor
Prehospital Center, Region Zealand
Responsible party
Niklas Breindahl (Principal Investigator, Prehospital Center, Region Zealand) — Principal investigator
First posted
Mar 15, 2024
Start date
May 1, 2024 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 25, 2024

Study contacts

Niklas Breindahl, MD
Contact
niklas.breindahl@gmail.com
+4528566410
Helle Collatz Christensen, MD, PhD
study director · pre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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