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Recruiting NCT06334276

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

— Observational Drowning Drowning, Near Drowning; Asphyxia Drowning and Nonfatal Submersion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drowning.
Who it may be relevant to
Registry conditions: Drowning, Drowning, Near, Drowning; Asphyxia, Drowning and Nonfatal Submersion. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

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

Primary outcome measures

  • 30-day mortality [Time frame: 30 days after the drowning incident]
  • Neurological outcome [Time frame: 30 days after the drowning incident]
Secondary outcome measures (6)
  • Hospital length of stay [Time frame: Immediately after hospital discharge]
  • Intensive care unit admission [Time frame: Immediately after hospital discharge]
  • Intensive care unit length of stay [Time frame: Immediately after hospital discharge]
  • Need for mechanical ventilation [Time frame: Immediately after hospital discharge]
  • Duration of mechanical ventilation [Time frame: Immediately after hospital discharge]
  • Survival to hospital discharge [Time frame: Immediately after hospital discharge]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Prehospital Center Region Zealand — Næstved

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. PMID 37619443

Identifiers

NCT: NCT06334276 · DROWN_INHOS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗