ClinicalTrials.gg
Active, not recruitingNCT06310525DROWN_DDF2Updated Aug 27, 2025

Using Machine Learning to Optimise the Danish Drowning Formula

An observational study in Drowning, Drowning and Submersion While in Bath-Tub and Drowning and Submersion While in Natural Water, sponsored by Prehospital Center, Region Zealand. Active, not recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by Prehospital Center, Region Zealand · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Sex
All
01

Study 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.

Read the detailed description

The DDF was published in 2023. It is a text-search algorithm designed to search the unstructured text fields in databases containing electronic medical records to identify all potential water-related incidents. The DDF consists of numerous trigger words related to submersion injury (e.g., "drukn"/ drown, "vand"/water, "hav"/ocean, and "båd"/ boat).

An ongoing study showed impressive performance metrics of the DDF as a drowning identification tool when applied to the Danish PEMR on unrestricted terms. However, the PPV was low for detecting drowning incidents specifically. This study aims to augment the DDF's positive predictive value and reduce the temporal demands associated with manual validation.

Data are extracted from the Danish nationwide Prehospital Electronic Medical Record using the DDF and manually validated before entered into the Danish Prehospital Drowning Data (DPDD).

Data from the DPDD from 2016-2021 will be split into 80% (training data) and 20% (test data) and used to train the machine learning.

Data from the DPDD from 2022-2023 will be used as validation data to calculate the performance metrics for the machine learning.

02

Conditions studied

  • Drowning
  • Drowning and Submersion While in Bath-Tub
  • Drowning and Submersion While in Natural Water
  • Drowning and Submersion While in Swimming-Pool
  • Drowning and Submersion Due to Fall Off Ship
  • Drowning and Nonfatal Submersion
  • Drowning, Near
  • Drowning; Asphyxia

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Keywords

  • Danish Drowning Formula
  • Epidemiology
  • Drowning
  • Machine learning
  • Text search
  • Utstein
  • Prehospital
  • Register
  • Database
  • Denmark
03

In context

Drowning

21 studies on the registry are indexed under Drowning; 6 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 1,099 across 14 observational studies indexed under Drowning.

Browse Drowning studies →

Lead sponsor

Prehospital Center, Region Zealand is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Duplets
  • Invalid civil registration number
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherDrowning incident

    Drowning was defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid".

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. PPV of the machine learning algorithm

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

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

  4. NPV of the machine learning algorithm

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

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

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 37619443 ↗
  • 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. PubMed 38448994 ↗
  • Breindahl N, Bitzer K, Sorensen OB, Wildenschild A, Wolthers SA, Lindskou T, Steinmetz J, Blomberg SNF, Christensen HC; Danish Drowning Validation Group. The Danish Drowning Cohort: Utstein-style data from fatal and non-fatal drowning incidents in Denmark. BMC Med Res Methodol. 2025 Jan 30;25(1):28. doi: 10.1186/s12874-025-02483-8. PubMed 39885431 ↗

Individual participant data

Plan to share: No — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Dec 2025, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2024
First posted
Mar 15, 2024
StartActual
Jan 1, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Aug 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06310525
Lead sponsor
Prehospital Center, Region Zealand
Responsible party
Niklas Breindahl (Principal Investigator, Region Zealand) — Principal investigator
First posted
Mar 15, 2024
Start date
Jan 1, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 27, 2025

Study contacts

Helle Collatz Christensen, Ass. Prof.
study director · Prehospital Center, Region Zealand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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