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NCT Number: NCT06334276

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drowning

Other

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

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days after the drowning incident

    The patient died before 30 days after the drowning incident

  2. Neurological outcome

    Time frame: 30 days after the drowning incident

    Using the modified Ranking Scale (mRS) score

Secondary outcomes

  1. Hospital length of stay

    Time frame: Immediately after hospital discharge

    Continuous

  2. Intensive care unit admission

    Time frame: Immediately after hospital discharge

    Binary

  3. Intensive care unit length of stay

    Time frame: Immediately after hospital discharge

    Continuous

  4. Need for mechanical ventilation

    Time frame: Immediately after hospital discharge

    Binary

  5. Duration of mechanical ventilation

    Time frame: Immediately after hospital discharge

    Continuous

  6. Survival to hospital discharge

    Time frame: Immediately after hospital discharge

    Binary

Study contacts

Contact information is provided by the study sponsor or research team.

Niklas Breindahl, MD

CONTACT

[email protected]

28566410

Sponsors and collaborators

Lead sponsor

Prehospital Center, Region Zealand

Other

Registry information

Acronym: DROWN_INHOS

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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