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

NCT ID: NCT06334276

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fatal drowning

This group of patients have died before 30 days after the drowning incident.

Drowning

Intervention Type OTHER

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.

Drowning

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Drowning

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Prehospital Center, Region Zealand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Niklas Breindahl

Principel Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Helle Collatz Christensen, Ass. Prof.

Role: STUDY_DIRECTOR

Prehospital Center, Region Zealand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prehospital Center Region Zealand

Næstved, Region Sjælland, Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Niklas Breindahl, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Niklas Breindahl, MD

Role: primary

004528566410

Helle Collatz Christensen, MD, PhD

Role: backup

004521673452

Niklas Breindahl, MD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 37619443 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DROWN_INHOS

Identifier Type: -

Identifier Source: org_study_id