NCT06312202

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

March 8, 2024

Last Update Submit

March 21, 2024

Conditions

Keywords

Danish Drowning FormulaDanish Prehospital Drowning DataDenmarkRegistryDatabaseCohortDrowningHarbourEmergency Medical ServiceSubmersion

Outcome Measures

Primary Outcomes (2)

  • Yearly incidence of drowning incidents

    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

    Cumulated counts of fatal to non-fatal drowning incidents from 2016-2023

    30 days after the drowning incident

Secondary Outcomes (1)

  • Assess risk factors associated with 30-day mortality

    30 days after the drowning incident

Study Arms (2)

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

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

Interventions

Drowning is defined as the process of experiencing respiratory impairment from submersion or immersion in liquid.

Fatal drowningNon-fatal drowning

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Incidents registered at GPS coordinates corresponding to a Danish harbour OR
  • Incidents identified using advanced text-search algorithm searching for "harbour"-related words

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prehospital Center

Næstved, Region Sjælland, 4700, Denmark

Location

Related 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.

    PMID: 37619443BACKGROUND

MeSH Terms

Conditions

DrowningHypoxiaNear DrowningAsphyxia

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Helle Collatz Christensen, MD, PhD

    pre

    STUDY DIRECTOR

Central Study Contacts

Niklas Breindahl, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 15, 2024

Study Start

May 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 25, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

The datasets used and analysed during the current study are available from the corresponding author upon reasonable request.

Locations