NCT06310525

Brief Summary

The Danish Drowning Formula (DDF) was designed to search the unstructured text fields in the Danish nationwide Prehospital Electronic Medical Record on unrestricted terms with comprehensive search criteria to identify all potential water-related incidents and achieve a high sensitivity. This was important as drowning is a rare occurrence, but it resulted in a low Positive Predictive Value for detecting drowning incidents specifically. This study aims to augment the positive predictive value of the DDF and reduce the temporal demands associated with manual validation.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
active not 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, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

March 7, 2024

Last Update Submit

August 20, 2025

Conditions

Keywords

Danish Drowning FormulaEpidemiologyDrowningMachine learningText searchUtsteinPrehospitalRegisterDatabaseDenmark

Outcome Measures

Primary Outcomes (4)

  • Sensitivity of the machine learning algorithm as a drowning identification tool

    Sensitivity \[TP / (TP+FN)\] will be calculated to show the performance of the machine learning as a drowning identification tool.

    The sensitivity of the trained machine learning will be calculated based on data from 2022 and 2023.

  • Specificity of the machine learning algorithm as a drowning identification tool

    Specificity \[TN / (FP+TN)\] will be calculated to show the performance of the machine learning as a drowning identification tool.

    The specificity of the trained machine learning will be calculated based on data from 2022 and 2023.

  • PPV of the machine learning algorithm

    PPV \[TP / (TP+FP)\] will be calculated to show the machine learning test result.

    The PPV of the trained machine learning will be calculated based on data from 2022 and 2023.

  • NPV of the machine learning algorithm

    NPV \[TN / (FN+TN)\] will be calculated to show the machine learning test result.

    The NPV of the trained machine learning will be calculated based on data from 2022 and 2023.

Study Arms (2)

Fatal drowning

Drowning incidents where the patient died within 30 days after the incident as a consequence of the submersion injury

Other: Drowning incident

Non-fatal drowning

Drowning incidents where the patient survived to 30 days

Other: Drowning incident

Interventions

Drowning was defined by the WHO in 2002 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

All fatal and non-fatal drowning patients in Denmark treated by the Emergency Medical Services (EMS) between 2016 and 2023.

You may qualify if:

  • The patient must have been experiencing respiratory impairment from submersion or immersion in liquid (including persistent coughing, respiratory arrest, and unconsciousness).
  • The patient must have been in contact with the Danish prehospital Emergency Medical Services.

You may not qualify if:

  • Duplets
  • Invalid civil registration number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prehospital Center

Næstved, Region Sjælland, 4700, Denmark

Location

Related Publications (2)

  • 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
  • Breindahl N, Wolthers SA, Moller TP, Blomberg SNF, Steinmetz J, Christensen HC; Danish Drowning Validation Group. Characteristics and critical care interventions in drowning patients treated by the Danish Air Ambulance from 2016 to 2021: a nationwide registry-based study with 30-day follow-up. Scand J Trauma Resusc Emerg Med. 2024 Mar 6;32(1):17. doi: 10.1186/s13049-024-01189-y.

    PMID: 38448994BACKGROUND

MeSH Terms

Conditions

DrowningNear DrowningAsphyxia

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Helle Collatz Christensen, Ass. Prof.

    Prehospital Center, Region Zealand

    STUDY DIRECTOR

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 7, 2024

First Posted

March 15, 2024

Study Start

January 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The data are intended for use nationally and internationally by researchers to reduce the incidence, mortality, and morbidity of drowning. The data are available upon reasonable request from researchers after application to the corresponding author, provided the necessary approvals are obtained from the relevant authorities.

Locations