DrowningDROWN_HARBORNCT06312202
Drowning Incidents in Danish Harbours
An observational study of Drowning and Drown, run by Prehospital Center, Region Zealand at 1 site in Denmark.
Trial summary
A recent study reported significantly increased mortality from drowning-related out-of-hospital cardiac arrest in Danish harbours compared to other public places (e.g., public pools, coastlines, and lakes). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drowning, Drown, Drowning; Anoxia
- What is being tested?
- Drowning
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2024to 31 Dec 2024
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target condition in this study is drowning, irrespective of follow-up at 30 days (fatal or non-fatal). We used the WHO definition of drowning supported by the clarification statement for non-fatal drowning as the case definition to identify drowning (target condition) during the manual validation. The study unit is the individual drowning patient. The target population are all fatal and non-fatal drowning patients in Danish harbours treated by the EMS in Denmark since 2016. Due to the comprehensive search criteria in the Danish Drowning Formula, it is reasonable to believe that the target population is identical to the study population.
Who may be able to join
- All the patients registered in the Danish Prehospital Drowning Data from 2016-2023 will be assessed for inclusion AND
- Incidents registered at GPS coordinates corresponding to a Danish harbour OR
- Incidents identified using advanced text-search algorithm searching for "harbour"-related words
Who cannot join
- Patients without a 30-day follow-up (e.g., due to missing or invalid civil registration numbers) and patients with a valid DNAR code will be excluded from the mortality analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatal and Non-fatal Drowning Incidents in Danish Harbours: a Nationwide Registry-based Study Using the Danish Prehospital Drowning Data From 2016-2023
A recent study reported significantly increased mortality from drowning-related out-of-hospital cardiac arrest in Danish harbours compared to other public places (e.g., public pools, coastlines, and lakes). Accurate and reliable data are necessary before establishing specific educational, preventative, rescue, or treatment strategies to reduce the number of drowning incidents in Danish harbours and improve survival. Therefore, it is essential to characterise drowning incidents in Danish harbours and analyse risk factors associated with fatal drowning.
Read the detailed description
Based on the GPS coordinates and advanced text-searching, it is possible to identify drowning incidents in Danish harbours and extract data from the Danish Prehospital Drowning Data.
This study is a nationwide registry-based study with data from the Danish Prehospital Drowning Data from 2016 to 2023. In this study, we will use 30-day mortality to differentiate between fatal and non-fatal drowning.
The primary objective is to estimate the yearly incidence of fatal and non-fatal drowning incidents in Danish harbours treated by the EMS from 2016 to 2023 and calculate the fatal to non-fatal ratio. The secondary objective is to assess risk factors associated with 30-day mortality.
- Conditions
- Drowning, Drown, Drowning; Anoxia, Drowning, Near, Drowning; Asphyxia, Drowning and Nonfatal Submersion
- Being tested
- Drowning
- Keywords
- Danish Drowning Formula, Danish Prehospital Drowning Data, Denmark, Registry, Database, Cohort, Drowning, Harbour, Emergency Medical Service, Submersion
- 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 |
|---|---|---|
| Fatal drowning | This group of patients experienced a drowning incident defined as the process of experiencing respiratory impairment from submersion or immersion in liquid and died within 30 days after the incident as a consequence of the submersion injury. Receives: Other: Drowning | |
| Non-fatal drowning | This group of patients experienced a drowning incident defined as the process of experiencing respiratory impairment from submersion or immersion in liquid and survived until 30 days after the incident. Receives: Other: Drowning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yearly incidence of drowning incidents
Yearly incidence of fatal and non-fatal drowning incidents in Danish harbours treated by the EMS from 2016-2023
Measured: 30 days after the drowning incident
Fatal to non-fatal drowning ratio
Cumulated counts of fatal to non-fatal drowning incidents from 2016-2023
Measured: 30 days after the drowning incident
Secondary outcomes (1)
Assess risk factors associated with 30-day mortality
Hypothesis-driven assessment of risk factors associated with drowning-related 30-day mortality
Measured: 30 days after the drowning incident
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 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- 400 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, MD, PhD, Study director, pre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312202
- Sponsor's protocol ID
- DROWN_HARBOUR
- Acronym
- DROWN_HARBOR
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 25 Mar 2024
- 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 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatal and Non-fatal Drowning Incidents in Danish Harbours: a Nationwide Registry-based Study Using the Danish Prehospital Drowning Data From 2016-2023
- ClinicalTrials.gov ID
- NCT06312202
- Acronym / sponsor ID
- DROWN_HARBOR / DROWN_HARBOUR
- Conditions
- Drowning, Drown, Drowning; Anoxia, Drowning, Near, Drowning; Asphyxia, Drowning and Nonfatal Submersion
- Keywords
- Danish Drowning Formula, Danish Prehospital Drowning Data, Denmark, Registry, Database, Cohort, Drowning, Harbour
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Prehospital Center, Region ZealandUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (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.
A recent study reported significantly increased mortality from drowning-related out-of-hospital cardiac arrest in Danish harbours compared to other public places (e.g., public pools, coastlines, and lakes). Accurate and reliable data are necessary before establishing specific educational, preventative, rescue, or treatment strategies to reduce the number of drowning incidents in Danish harbours and improve survival. Therefore, it is essential to characterise drowning incidents in Danish harbours and analyse risk factors associated with fatal drowning.
Detailed description
Based on the GPS coordinates and advanced text-searching, it is possible to identify drowning incidents in Danish harbours and extract data from the Danish Prehospital Drowning Data.
This study is a nationwide registry-based study with data from the Danish Prehospital Drowning Data from 2016 to 2023. In this study, we will use 30-day mortality to differentiate between fatal and non-fatal drowning.
The primary objective is to estimate the yearly incidence of fatal and non-fatal drowning incidents in Danish harbours treated by the EMS from 2016 to 2023 and calculate the fatal to non-fatal ratio. The secondary objective is to assess risk factors associated with 30-day mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatal drowning | – | Other: DrowningThis group of patients experienced a drowning incident defined as the process of experiencing respiratory impairment from submersion or immersion in liquid and died within 30 days after the incident as a consequence of the submersion injury. |
| Non-fatal drowning | – | Other: DrowningThis group of patients experienced a drowning incident defined as the process of experiencing respiratory impairment from submersion or immersion in liquid and survived until 30 days after the incident. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target condition in this study is drowning, irrespective of follow-up at 30 days (fatal or non-fatal). We used the WHO definition of drowning supported by the clarification statement for non-fatal drowning as the case definition to identify drowning (target condition) during the manual validation. The study unit is the individual drowning patient. The target population are all fatal and non-fatal drowning patients in Danish harbours treated by the EMS in Denmark since 2016. Due to the comprehensive search criteria in the Danish Drowning Formula, it is reasonable to believe that the target population is identical to the study population.
Key inclusion criteria (3 listed)
- All the patients registered in the Danish Prehospital Drowning Data from 2016-2023 will be assessed for inclusion AND
- Incidents registered at GPS coordinates corresponding to a Danish harbour OR
- Incidents identified using advanced text-search algorithm searching for "harbour"-related words
Key exclusion criteria (1 listed)
- Patients without a 30-day follow-up (e.g., due to missing or invalid civil registration numbers) and patients with a valid DNAR code will be excluded from the mortality analysis.
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 | Fatal drowning, Non-fatal drowning |
Primary outcome
Yearly incidence of drowning incidents
Time frame: 30 days after the drowning incident
Yearly incidence of fatal and non-fatal drowning incidents in Danish harbours treated by the EMS from 2016-2023
Fatal to non-fatal drowning ratio
Time frame: 30 days after the drowning incident
Cumulated counts of fatal to non-fatal drowning incidents from 2016-2023
1 secondary outcome
Assess risk factors associated with 30-day mortality
Time frame: 30 days after the drowning incident
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- 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 study director
pre
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 Drown, 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 3 inclusion and 1 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 25 Mar 2024. 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 (+4528566410, niklas.breindahl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yearly incidence of drowning incidents (time frame: 30 days after the drowning incident). 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 NCT06312202, 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 25 Mar 2024.