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

Recruiting

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

• Registration Number: NCT06334276
• Lead Sponsor: Prehospital Center, Region Zealand

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.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fatal drowning	Drowning	This group of patients have died before 30 days after the drowning incident.
Non-fatal drowning	Drowning	This group of patients have survived until 30 days after the drowning incident.

Primary Outcome Measures

Name	Time	Method
30-day mortality	30 days after the drowning incident	The patient died before 30 days after the drowning incident
Neurological outcome	30 days after the drowning incident	Using the modified Ranking Scale (mRS) score

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	Immediately after hospital discharge	Continuous
Duration of mechanical ventilation	Immediately after hospital discharge	Continuous
Survival to hospital discharge	Immediately after hospital discharge	Binary
Need for mechanical ventilation	Immediately after hospital discharge	Binary
Intensive care unit admission	Immediately after hospital discharge	Binary
Intensive care unit length of stay	Immediately after hospital discharge	Continuous

Trial Locations

Locations (1)

Prehospital Center Region Zealand; 🇩🇰 Næstved, Region Zealand, Denmark