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

Drowning Clinical Trial

— DROWN_INHOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334276
• Other study ID #: DROWN_INHOS
• Status: Not yet recruiting
• Start date: January 1, 2025
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Prehospital Center, Region Zealand
• Contact: Niklas Breindahl, MD
• Phone: 28566410
• Email: niklas.breindahl[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Asphyxia
• Drowning

Intervention

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

Locations

Country	Name	City	State
Denmark	Prehospital Center	Næstved	Region Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Prehospital Center, Region Zealand

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	The patient died before 30 days after the drowning incident	30 days after the drowning incident
Primary	Neurological outcome	Using the modified Ranking Scale (mRS) score	30 days after the drowning incident
Secondary	Hospital length of stay	Continuous	Immediately after hospital discharge
Secondary	Intensive care unit admission	Binary	Immediately after hospital discharge
Secondary	Intensive care unit length of stay	Continuous	Immediately after hospital discharge
Secondary	Need for mechanical ventilation	Binary	Immediately after hospital discharge
Secondary	Duration of mechanical ventilation	Continuous	Immediately after hospital discharge
Secondary	Survival to hospital discharge	Binary	Immediately after hospital discharge