Clinical trial NCT06312202: Drowning Incidents in Danish Harbours
Official title: Fatal and Non-fatal Drowning Incidents in Danish Harbours: a Nationwide Registry-based Study Using the Danish Prehospital Drowning Data From 2016-2023
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Drowning
Drown
Drowning; Anoxia
Drowning, Near
Drowning; Asphyxia
Drowning and Nonfatal Submersion
Drowning or Immersion of Unknown Intent
Drowning and Submersion, Undetermined Intent
Drowning and Submersion While in Natural Water
Drowning and Submersion Due to Sailboat Sinking
Drowning and Submersion Due to Fall Off Ship
Keywords: Danish Drowning Formula
Danish Prehospital Drowning Data
Denmark
Registry
Database
Cohort
Drowning
Harbour
Emergency Medical Service
Submersion
Lead sponsor: Prehospital Center, Region Zealand
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Yearly incidence of drowning incidents
timeFrame: 30 days after the drowning incident
measure: Fatal to non-fatal drowning ratio
timeFrame: 30 days after the drowning incident
Secondary outcomes:
measure: Assess risk factors associated with 30-day mortality
timeFrame: 30 days after the drowning incident
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Prehospital Center
state: Region Zealand
Study officials:
affiliation: pre
name: Helle Collatz Christensen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.