Clinical trial NCT06334276: Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016
Official title: Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: Danish Drowning Formula
Drowning
Danish Prehospital Drowning Data
Registry
Database
Emergency Medical Service
Utstein
Register
Epidemiology
Lead sponsor: Prehospital Center, Region Zealand
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fatal and non-fatal drowning persons from 2016 identified in the Danish Prehospital Drowning Data.

Brief 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.

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.

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.

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days after the drowning incident
measure: Neurological outcome
timeFrame: 30 days after the drowning incident
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Immediately after hospital discharge
measure: Intensive care unit admission
timeFrame: Immediately after hospital discharge
measure: Intensive care unit length of stay
timeFrame: Immediately after hospital discharge
measure: Need for mechanical ventilation
timeFrame: Immediately after hospital discharge
measure: Duration of mechanical ventilation
timeFrame: Immediately after hospital discharge
measure: Survival to hospital discharge
timeFrame: Immediately after hospital discharge
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Prehospital Center Region Zealand
state: Region Zealand
Study officials:
affiliation: Prehospital Center, Region Zealand
name: Helle Collatz Christensen, Ass. Prof.
role: STUDY_DIRECTOR
References:
citation: 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.