DrowningRESCUENCT06327893
Patients Treated by the Danish Emergency Medical Services Following Non-drowning Water Rescues From 2016 to 2023
An observational study of Drowning and Drowning, Near, run by Prehospital Center, Region Zealand at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drowning, Drowning, Near, Submersion
- What is being tested?
- Submersion or immersion in liquid
- How many people
- 3,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2016to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Helle Collatz Christensen, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Prehospital Center
Næstved, Region Sjælland, 4700
Niklas Breindahl, MD, PhD, 004528566410, niklas.breindahl@gmail.com
Helle Collatz Christensen, MD, PhD, 004521673452, Hcli@regsj.dk
About this study
Official title: Patients Treated by the Danish Emergency Medical Services Following Non-drowning Water Rescues From 2016 to 2023: A Danish Registry-based Study From 2016 to 2023
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.
Read the detailed description
Purpose The purpose of this study is to establish recommendations towards specific educational, preventative, or rescue strategies to reduce the number of aquatic rescues in Denmark (e.g., campaigns targeting high-risk groups, or fencing, allocating rescue equipment, or establishing lifeguard stations in high-risk areas). This may not only enhance prevention of aquatic rescues but also decrease the mortality and the total number of drowning incidents in Denmark.
Objectives The primary objective is to estimate the yearly incidence of patients treated by the Danish EMS following a non-drowning aquatic rescue from 2016 to 2023 and calculate the aquatic rescue to drowning ratio. The secondary objectives are to characterise the rescues (e.g., lay rescuer or professional rescuer, use of equipment) and to report the spatial distribution.
Study design This study is a nationwide registry-based study with data from the Danish nationwide PEMR from 2016 to 2023.
Methods 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 study will be the first 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.
- Conditions
- Drowning, Drowning, Near, Submersion, Submersion - Accidental, Submersion or Drowning Due to Being Washed Overboard, Submersion or Drowning Due to Being Thrown Overboard
- Being tested
- Submersion or immersion in liquid
- Keywords
- Water rescue, Aquatic rescue, Danish Prehospital Drowning Data, Danish Drowning Formula, Emergency Medical Service (EMS), Cohort, Registry, Utstein, Epidemiology
- Medical subject headings
- Drowning, Near Drowning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submersion or immersion in liquidOther
The patient must have been submersed or immersed in liquid.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Submersion or immersion in liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The annual incidence.
The incidence will be reported as the annual number of cases.
Measured: 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.
Measured: From 2016 to 2023.
Secondary outcomes (1)
The spatial distribution of aquatic rescues on a map of Denmark.
Each incident will be presented with a single entry based on the geographical coordinates of the incident.
Measured: From 2016-2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Jan 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DrowningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prehospital Center, Region Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niklas Breindahl, Prehospital Center, Region Zealand
- Investigators
- Helle Collatz Christensen, Ass. Prof., Study director, Prehospital Center, Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327893
- Sponsor's protocol ID
- AQUATIC_RESCUE
- Acronym
- RESCUE
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and analysed during the current study are available from the corresponding author upon reasonable request.
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Treated by the Danish Emergency Medical Services Following Non-drowning Water Rescues From 2016 to 2023: A Danish Registry-based Study From 2016 to 2023
- ClinicalTrials.gov ID
- NCT06327893
- Acronym / sponsor ID
- RESCUE / AQUATIC_RESCUE
- Conditions
- Drowning, Drowning, Near, Submersion, Submersion - Accidental, Submersion or Drowning Due to Being Washed Overboard, Submersion or Drowning Due to Being Thrown Overboard
- Keywords
- Water rescue, Aquatic rescue, Danish Prehospital Drowning Data, Danish Drowning Formula, Emergency Medical Service (EMS), Cohort, Registry, Utstein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Prehospital Center, Region ZealandUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose The purpose of this study is to establish recommendations towards specific educational, preventative, or rescue strategies to reduce the number of aquatic rescues in Denmark (e.g., campaigns targeting high-risk groups, or fencing, allocating rescue equipment, or establishing lifeguard stations in high-risk areas). This may not only enhance prevention of aquatic rescues but also decrease the mortality and the total number of drowning incidents in Denmark.
Objectives The primary objective is to estimate the yearly incidence of patients treated by the Danish EMS following a non-drowning aquatic rescue from 2016 to 2023 and calculate the aquatic rescue to drowning ratio. The secondary objectives are to characterise the rescues (e.g., lay rescuer or professional rescuer, use of equipment) and to report the spatial distribution.
Study design This study is a nationwide registry-based study with data from the Danish nationwide PEMR from 2016 to 2023.
Methods 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 study will be the first 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquatic rescue | – | Other: Submersion or immersion in liquidPatients 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Submersion or immersion in liquidThe patient must have been submersed or immersed in liquid. | Other | Aquatic rescue |
Primary outcome
The annual incidence.
Time frame: From 2016 to 2023.
The incidence will be reported as the annual number of cases.
The annual incidence rate.
Time frame: From 2016 to 2023.
The incidence rate will be reported as the annual number of cases per 100,000 person-years.
1 secondary outcome
The spatial distribution of aquatic rescues on a map of Denmark.
Time frame: From 2016-2023.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Background: PubMed 37619443Breindahl 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.
- Individual participant dataSharing planned: No. The datasets used and analysed during the current study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helle Collatz Christensen, MD, PhD contact
Helle Collatz Christensen, Ass. Prof. study director
Prehospital Center, Region Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drowning and Drowning, Near, run by Prehospital Center, Region Zealand at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niklas Breindahl, MD, PhD (28566410, niklas.breindahl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The annual incidence. (time frame: From 2016 to 2023.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06327893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.