Drowning Incidents in Danish Harbours (DROWN_HARBOR)

March 21, 2024 updated by: Niklas Breindahl, Prehospital Center, Region Zealand

Fatal and Non-fatal Drowning Incidents in Danish Harbours: a Nationwide Registry-based Study Using the Danish Prehospital Drowning Data From 2016-2023

A recent study reported significantly increased mortality from drowning-related out-of-hospital cardiac arrest in Danish harbours compared to other public places (e.g., public pools, coastlines, and lakes). Accurate and reliable data are necessary before establishing specific educational, preventative, rescue, or treatment strategies to reduce the number of drowning incidents in Danish harbours and improve survival. Therefore, it is essential to characterise drowning incidents in Danish harbours and analyse risk factors associated with fatal drowning.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Based on the GPS coordinates and advanced text-searching, it is possible to identify drowning incidents in Danish harbours and extract data from the Danish Prehospital Drowning Data.

This study is a nationwide registry-based study with data from the Danish Prehospital Drowning Data from 2016 to 2023. In this study, we will use 30-day mortality to differentiate between fatal and non-fatal drowning.

The primary objective is to estimate the yearly incidence of fatal and non-fatal drowning incidents in Danish harbours treated by the EMS from 2016 to 2023 and calculate the fatal to non-fatal ratio. The secondary objective is to assess risk factors associated with 30-day mortality.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target condition in this study is drowning, irrespective of follow-up at 30 days (fatal or non-fatal). We used the WHO definition of drowning supported by the clarification statement for non-fatal drowning as the case definition to identify drowning (target condition) during the manual validation.

The study unit is the individual drowning patient. The target population are all fatal and non-fatal drowning patients in Danish harbours treated by the EMS in Denmark since 2016. Due to the comprehensive search criteria in the Danish Drowning Formula, it is reasonable to believe that the target population is identical to the study population.

Description

Inclusion Criteria:

  • All the patients registered in the Danish Prehospital Drowning Data from 2016-2023 will be assessed for inclusion AND
  • Incidents registered at GPS coordinates corresponding to a Danish harbour OR
  • Incidents identified using advanced text-search algorithm searching for "harbour"-related words

Exclusion Criteria:

  • Patients without a 30-day follow-up (e.g., due to missing or invalid civil registration numbers) and patients with a valid DNAR code will be excluded from the mortality analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fatal drowning
This group of patients experienced a drowning incident defined as the process of experiencing respiratory impairment from submersion or immersion in liquid and died within 30 days after the incident as a consequence of the submersion injury.
Other: Drowning
Drowning is defined as the process of experiencing respiratory impairment from submersion or immersion in liquid.
Non-fatal drowning
This group of patients experienced a drowning incident defined as the process of experiencing respiratory impairment from submersion or immersion in liquid and survived until 30 days after the incident.
Other: Drowning
Drowning is defined 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
Yearly incidence of drowning incidents
Time Frame: 30 days after the drowning incident
Yearly incidence of fatal and non-fatal drowning incidents in Danish harbours treated by the EMS from 2016-2023
30 days after the drowning incident
Fatal to non-fatal drowning ratio
Time Frame: 30 days after the drowning incident
Cumulated counts of fatal to non-fatal drowning incidents from 2016-2023
30 days after the drowning incident

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess risk factors associated with 30-day mortality
Time Frame: 30 days after the drowning incident
Hypothesis-driven assessment of risk factors associated with drowning-related 30-day mortality
30 days after the drowning incident

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prehospital Center, Region Zealand

Investigators

  • Study Director: Helle Collatz Christensen, MD, PhD, Pre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DROWN_HARBOUR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and analysed during the current study 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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