ClinicalTrials.gg
RecruitingNCT06334276DROWN_INHOSUpdated Nov 29, 2024

Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016

An observational study in Drowning, Drowning, Near and Drowning; Asphyxia, sponsored by Prehospital Center, Region Zealand. Recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Prehospital Center, Region Zealand · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2016; still recruiting 10 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Sex
All
01

Study summary

This nationwide, registry-based study aims to link Danish Prehospital Drowning Data data with inhospital data to develop a Utstein-style Danish Drowning Registry. This study will report mortality and neurological outcomes 30 days after a drowning incident since 2016.

Read the detailed description

Purpose

The purpose of this study is to establish recommendations towards specific educational, preventative, rescue, or treatment strategies to reduce the number of fatal and non-fatal drowning incidents in Denmark (e.g., campaigns targeting high-risk groups, or fencing, allocating rescue equipment, or establishing lifeguard stations in high-risk areas).

Objectives

The primary objective is to estimate 30-day mortality of drowning incidents in Denmark treated by the Emergency Medical Services from 2016. The secondary objective is to explore risk factors associated with 30-day mortality.

Study design

A nationwide registry-based study linking data from the Danish Prehospital Drowning Data with data from the inhospital electronic medical records. from 2016 and follow-up on mortality 30 days after the drowning incident. Neurological outcomes will be assessed by trained observers through the inhospital electronic medical records.

02

Conditions studied

  • Drowning
  • Drowning, Near
  • Drowning; Asphyxia
  • Drowning and Nonfatal Submersion
  • Drowning or Immersion of Unknown Intent
  • Drowning and Submersion, Undetermined Intent
  • Drowning and Submersion While in Bath-Tub
  • Drowning and Submersion While in Natural Water
  • Drowning and Submersion While in Swimming-Pool

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Keywords

  • Danish Drowning Formula
  • Drowning
  • Danish Prehospital Drowning Data
  • Registry
  • Database
  • Emergency Medical Service
  • Utstein
  • Register
  • Epidemiology
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 1,500 is above 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

Fatal and non-fatal drowning persons from 2016 identified in the Danish Prehospital Drowning Data.

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

  • Drowning
  • Being registered in the Danish Prehospital Drowning Data with a valid civil registration number to allow for linkage with the inhospital electronic medical records

Exclusion criteria

Exclusion Criteria:

  • Obvious signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity).
  • Declared dead on scene.
  • A valid Do-Not-Attempt-Resuscitation order or other code status orders limiting life-sustaining therapies.
  • An invalid civil registration number.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Fatal drowning

    This group of patients have died before 30 days after the drowning incident.

    Other: Drowning

  • Non-fatal drowning

    This group of patients have survived until 30 days after the drowning incident.

    Other: Drowning

Interventions

  • OtherDrowning

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

06

What researchers measure

Primary outcomes

  1. 30-day mortality

    The patient died before 30 days after the drowning incident

    Time frame: 30 days after the drowning incident

  2. Neurological outcome

    Using the modified Ranking Scale (mRS) score

    Time frame: 30 days after the drowning incident

Secondary outcomes

  1. Hospital length of stay

    Continuous

    Time frame: Immediately after hospital discharge

  2. Intensive care unit admission

    Binary

    Time frame: Immediately after hospital discharge

  3. Intensive care unit length of stay

    Continuous

    Time frame: Immediately after hospital discharge

  4. Need for mechanical ventilation

    Binary

    Time frame: Immediately after hospital discharge

  5. Duration of mechanical ventilation

    Continuous

    Time frame: Immediately after hospital discharge

  6. Survival to hospital discharge

    Binary

    Time frame: Immediately after hospital discharge

07

Study locations

1 of 1 sites recruiting
  • Prehospital Center Region Zealand
    Næstved, Region Zealand 4700, Denmark
    Recruiting
    • Niklas Breindahl, MD · Contactnbrei@regsj.dk · 004528566410
    • Helle Collatz Christensen, MD, PhD · Contacthcli@regsj.dk · 004521673452
    • Niklas Breindahl, MD · Contact
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 — Data are available from the corresponding author upon reasonable request.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06334276
Lead sponsor
Prehospital Center, Region Zealand
Responsible party
Niklas Breindahl (Principel Investigator, Region Zealand) — Principal investigator
First posted
Mar 28, 2024
Start date
Jan 1, 2016
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Nov 29, 2024

Study contacts

Niklas Breindahl, MD
Contact
nbrei@regsj.dk
28566410
Helle Collatz Christensen, Ass. Prof.
study director · Prehospital Center, Region Zealand

Oversight

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

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