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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06312202
Other study ID # DROWN_HARBOUR
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Prehospital Center, Region Zealand
Contact Niklas Breindahl, MD
Phone +4528566410
Email niklas.breindahl@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Drowning
Drowning is defined 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 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
Primary 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 Assess risk factors associated with 30-day mortality Hypothesis-driven assessment of risk factors associated with drowning-related 30-day mortality 30 days after the drowning incident
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