DrowningDROWN_CODNCT06310499
Primary or Secondary Drowning
An observational study of Drowning and Drowning; Anoxia, run by Prehospital Center, Region Zealand at 1 site in Denmark.
Trial summary
According to WHO's rules, any death certificate must state the underlying cause of death and contributory causes of death may also be stated. Differentiating between primary and secondary drowning is difficult, as information preceding the drowning incident is rarely available. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drowning, Drowning; Anoxia, Drowning, Near
- What is being tested?
- Drowning
- How many people
- 700 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2016to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Danish Prehospital Drowning Data reports prehospital data on patients with fatal and non-fatal drowning treated by the Emergency Medical Services in Denmark since 2016. Drowning incidents are identified from the Danish Prehospital Electronic Medical Record using the Danish Drowning Formula and extensive manual validation. Data is extracted following the revised USFD. The patients' unique civil registration number enable linkage with the Civil Personal Register to obtain data on 30-day survival and differentiate between fatal and non-fatal drowning incidents
Who may be able to join
- All drowning patients registered in the Danish Prehospital Drowning Data AND
- Having a fatal outcome within 30 days after the drowning incident AND
- Having a valid civil registration number in the Danish Prehospital Drowning Data
- Being able to link data from the Danish Register of Causes of Death
Who cannot join
- Patients alive 30 days after the drowning incident
- Patients with an invalid civil registration number in the Danish Prehospital Drowning Data
- Patients where data cannot be retrieved from the Danish Register of Causes of Death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary or Secondary Fatal Drowning? A Registry-based Study Analysing Autopsy Reports From Patients Registered in the Danish Prehospital Drowning Data
According to WHO's rules, any death certificate must state the underlying cause of death and contributory causes of death may also be stated.
Differentiating between primary and secondary drowning is difficult, as information preceding the drowning incident is rarely available. Yet, knowing the most frequent causes of secondary drowning may provide useful information to healthcare professionals working in prehospital Emergency Medical Services, as this may affect prehospital treatment.
Read the detailed description
The annual death statistics are based solely on the underlying cause of death, that is the disease or condition which started the process that led to death. The conditions that directly caused the death are also to be stated by the physician on the death certificate and may be included in the statistics. In research projects, data on those contributory causes of death may be drawn from the register. It is now the medical doctor who has verified the death and issued the death certificate indicating the underlying and contributory causes of death, who also classifies these causes in accordance with ICD-10 and fills in the coded data on the electronic death certificate. The Danish Register of Causes of Death is, thus, updated without central validation of the classification and relies entirely on the coding done by individual physicians.
This study aims to characterise fatal drowning incidents as primary or secondary drownings and report the frequencies of secondary drowning causes.
- Conditions
- Drowning, Drowning; Anoxia, Drowning, Near, Drowning in Swimming Pool, Drowning; Asphyxia, Drowning/Diving/SCUBA Accident
- Being tested
- Drowning
- Keywords
- Drowning, Epidemiology, Danish Prehospital Drowning Data, Danish Drowning Formula, Registry, Cohort, Autopsy, Cause of death, Death certificate, Database, Denmark, Utstein
- Medical subject headings
- Drowning, Hypoxia, Near Drowning, Asphyxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrowningOther
Drowning is defined as the process of experiencing respiratory impairment from submersion or immersion in liquid.
| Study group | Role | What they receive |
|---|---|---|
| Primary fatal drowning | These patients are registered in the Danish Register of Causes of Death, with drowning as an underlying cause of death in the death certificate. Receives: Other: Drowning | |
| Secondary fatal drowning | These patients are registered in the Danish Register of Causes of Death, with drowning as a contributory cause of death or drowning not registered in the death certificate. Receives: Other: Drowning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autopsy rate
Calculated as the number of autopsy reports divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.
Measured: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Primary fatal drowning rate
Calculated as the number of autopsy reports stating drowning as the underlying cause of death divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.
Measured: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Secondary fatal drowning rate
Calculated as the number of autopsy reports stating drowning as the contributory cause of death OR not stating drowning as a contributory cause of death divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.
Measured: Data is extracted on patients registered in the Danish Prehospital Drowning Data 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 posted15 Mar 2024
- Study start1 Jan 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 700 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
- NCT06310499
- Sponsor's protocol ID
- DROWN_COD
- Acronym
- DROWN_COD
- Status last verified
- Aug 2025
- First submitted
- 7 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 data are available upon reasonable request from researchers after application to the corresponding author, provided the necessary approvals are obtained from the relevant authorities.
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 37619443Helweg-Larsen K. The Danish Register of Causes of Death. Scand J Public Health. 2011 Jul;39(7 Suppl):26-9. doi: 10.1177/1403494811399958.
PubMed 21775346Breindahl 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
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
- Primary or Secondary Fatal Drowning? A Registry-based Study Analysing Autopsy Reports From Patients Registered in the Danish Prehospital Drowning Data
- ClinicalTrials.gov ID
- NCT06310499
- Acronym / sponsor ID
- DROWN_COD / DROWN_COD
- Conditions
- Drowning, Drowning; Anoxia, Drowning, Near, Drowning in Swimming Pool, Drowning; Asphyxia, Drowning/Diving/SCUBA Accident
- Keywords
- Drowning, Epidemiology, Danish Prehospital Drowning Data, Danish Drowning Formula, Registry, Cohort, Autopsy, Cause of death
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 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
- 31 Dec 2026 (estimated)
- First posted
- 15 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.
According to WHO's rules, any death certificate must state the underlying cause of death and contributory causes of death may also be stated.
Differentiating between primary and secondary drowning is difficult, as information preceding the drowning incident is rarely available. Yet, knowing the most frequent causes of secondary drowning may provide useful information to healthcare professionals working in prehospital Emergency Medical Services, as this may affect prehospital treatment.
Detailed description
The annual death statistics are based solely on the underlying cause of death, that is the disease or condition which started the process that led to death. The conditions that directly caused the death are also to be stated by the physician on the death certificate and may be included in the statistics. In research projects, data on those contributory causes of death may be drawn from the register. It is now the medical doctor who has verified the death and issued the death certificate indicating the underlying and contributory causes of death, who also classifies these causes in accordance with ICD-10 and fills in the coded data on the electronic death certificate. The Danish Register of Causes of Death is, thus, updated without central validation of the classification and relies entirely on the coding done by individual physicians.
This study aims to characterise fatal drowning incidents as primary or secondary drownings and report the frequencies of secondary drowning causes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary fatal drowning | – | Other: DrowningThese patients are registered in the Danish Register of Causes of Death, with drowning as an underlying cause of death in the death certificate. |
| Secondary fatal drowning | – | Other: DrowningThese patients are registered in the Danish Register of Causes of Death, with drowning as a contributory cause of death or drowning not registered in the death certificate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Danish Prehospital Drowning Data reports prehospital data on patients with fatal and non-fatal drowning treated by the Emergency Medical Services in Denmark since 2016. Drowning incidents are identified from the Danish Prehospital Electronic Medical Record using the Danish Drowning Formula and extensive manual validation. Data is extracted following the revised USFD. The patients' unique civil registration number enable linkage with the Civil Personal Register to obtain data on 30-day survival and differentiate between fatal and non-fatal drowning incidents
Key inclusion criteria (4 listed)
- All drowning patients registered in the Danish Prehospital Drowning Data AND
- Having a fatal outcome within 30 days after the drowning incident AND
- Having a valid civil registration number in the Danish Prehospital Drowning Data
- Being able to link data from the Danish Register of Causes of Death
Key exclusion criteria (3 listed)
- Patients alive 30 days after the drowning incident
- Patients with an invalid civil registration number in the Danish Prehospital Drowning Data
- Patients where data cannot be retrieved from the Danish Register of Causes of Death
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 |
|---|---|---|
| DrowningDrowning is defined as the process of experiencing respiratory impairment from submersion or immersion in liquid. | Other | Primary fatal drowning, Secondary fatal drowning |
Primary outcome
Autopsy rate
Time frame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Calculated as the number of autopsy reports divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.
Primary fatal drowning rate
Time frame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Calculated as the number of autopsy reports stating drowning as the underlying cause of death divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.
Secondary fatal drowning rate
Time frame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Calculated as the number of autopsy reports stating drowning as the contributory cause of death OR not stating drowning as a contributory cause of death divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
- Background: PubMed 21775346Helweg-Larsen K. The Danish Register of Causes of Death. Scand J Public Health. 2011 Jul;39(7 Suppl):26-9. doi: 10.1177/1403494811399958.
- Derived from this study: PubMed 39885431Breindahl 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.
- Individual participant dataSharing planned: No. 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.
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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, 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; Anoxia, 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 4 inclusion and 3 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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autopsy rate (time frame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.). The study lists 3 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 NCT06310499, which also lists 3 linked publications.
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.