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

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.

Study Overview

• Status: Not yet 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
• Intervention / Treatment: Other: Drowning

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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Niklas Breindahl, MD; Phone Number: 28566410; Email: niklas.breindahl@gmail.com

Study Locations

• Denmark
  • Region Zealand
    • Næstved, Region Zealand, Denmark, 4700
      • Prehospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fatal drowning; This group of patients have died before 30 days after the drowning incident.	Other: Drowning; Drowning is defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid"
Non-fatal drowning; This group of patients have survived until 30 days after the drowning incident.	Other: Drowning; Drowning is defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid"

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Continuous	Immediately after hospital discharge
Intensive care unit admission	Binary	Immediately after hospital discharge
Intensive care unit length of stay	Continuous	Immediately after hospital discharge
Need for mechanical ventilation	Binary	Immediately after hospital discharge
Duration of mechanical ventilation	Continuous	Immediately after hospital discharge
Survival to hospital discharge	Binary	Immediately after hospital discharge

Collaborators and Investigators

• Sponsor: Prehospital Center, Region Zealand
• Investigators: Study Director: Helle Collatz Christensen, Ass. Prof., Prehospital Center, Region Zealand

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Epidemiology; Registry; Database; Utstein; Register; Emergency Medical Service; Drowning; Danish Drowning Formula; Danish Prehospital Drowning Data
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Death; Asphyxia; Drowning; Near Drowning
• Other Study ID Numbers: DROWN_INHOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data are available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No