NCT06327893

Brief Summary

Since 2015, all Danish prehospital EMS have used the nationwide Prehospital Electronic Medical Record (PEMR). In 2023, the investigators developed the Danish Drowning Formula (DDF), a text-search algorithm designed to search the unstructured text fields in the electronic medical records with comprehensive search criteria to identify all potential water-related incidents. This protocol describes the first study to analyse the prehospital data from a nationwide Danish cohort of patients treated by the EMS from 2016 to 2023 following non-drowning aquatic rescues.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

January 1, 2016

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 27, 2025

Status Verified

March 1, 2024

Enrollment Period

10 years

First QC Date

March 18, 2024

Last Update Submit

August 20, 2025

Conditions

Keywords

Water rescueAquatic rescueDanish Prehospital Drowning DataDanish Drowning FormulaEmergency Medical Service (EMS)CohortRegistryUtsteinEpidemiology

Outcome Measures

Primary Outcomes (2)

  • The annual incidence.

    The incidence will be reported as the annual number of cases.

    From 2016 to 2023.

  • The annual incidence rate.

    The incidence rate will be reported as the annual number of cases per 100,000 person-years.

    From 2016 to 2023.

Secondary Outcomes (1)

  • The spatial distribution of aquatic rescues on a map of Denmark.

    From 2016-2023.

Study Arms (1)

Aquatic rescue

Patients treated by the Danish EMS following an aquatic rescue performed by lay or professional rescuers are identified from the Danish PEMR using the Danish Drowning Formula (DDF) and extensive manual validation.

Other: Submersion or immersion in liquid

Interventions

The patient must have been submersed or immersed in liquid.

Aquatic rescue

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated by the Danish EMS following an aquatic rescue are identified from the Danish Prehospital Electronic Medical Record using the Danish Drowning Formula and extensive manual validation. We used the WHO definition of drowning supported by the "Clarification and Categorisation of Non-fatal Drowning" statement to differentiate between drowning and non-drowning aquatic rescues.

You may qualify if:

  • All the patients registered in the Danish Prehospital Electronic Medical Record from 2016-2023 will be screened by the Danish Drowning Formula and the medical records containing one or more trigger words will be extracted for manual validation.
  • All records where the patient was immersed or submersed in liquid but did not experience mild, moderate, or severe respiratory impairment following the drowning process will be included.

You may not qualify if:

  • All records where the patient was immersed or submersed in liquid and did experience mild, moderate, or severe respiratory impairment following the drowning process).
  • All records where the patient was not immersed or submersed in liquid.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prehospital Center

Næstved, Region Sjælland, 4700, Denmark

RECRUITING

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

DrowningNear Drowning

Interventions

ImmersionFluid Therapy

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative TechniquesDrug TherapyTherapeutics

Study Officials

  • Helle Collatz Christensen, Ass. Prof.

    Prehospital Center, Region Zealand

    STUDY DIRECTOR

Central Study Contacts

Niklas Breindahl, MD, PhD

CONTACT

Helle Collatz Christensen, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 25, 2024

Study Start

January 1, 2016

Primary Completion

December 31, 2025

Study Completion

May 1, 2026

Last Updated

August 27, 2025

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