DrowningDROWN_INHOSNCT06334276
Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016
An observational study of Drowning and Drowning, Near, run by Prehospital Center, Region Zealand at 1 site in Denmark.
Trial summary
This nationwide, registry-based study aims to link Danish Prehospital Drowning Data data with inhospital data to develop a Utstein-style Danish Drowning Registry. This study will report mortality and neurological outcomes 30 days after a drowning incident since 2016. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drowning, Drowning, Near, Drowning; Asphyxia
- What is being tested?
- Drowning
- How many people
- 1,500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2016to 31 Dec 2025
- 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: Fatal and non-fatal drowning persons from 2016 identified in the Danish Prehospital Drowning Data.
Who may be able to join
- Drowning
- Being registered in the Danish Prehospital Drowning Data with a valid civil registration number to allow for linkage with the inhospital electronic medical records
Who cannot join
- Obvious signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity).
- Declared dead on scene.
- A valid Do-Not-Attempt-Resuscitation order or other code status orders limiting life-sustaining therapies.
- An invalid civil registration number.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Prehospital Center Region Zealand
Næstved, Region Sjælland, 4700
Niklas Breindahl, MD, 004528566410, nbrei@regsj.dk
Helle Collatz Christensen, MD, PhD, 004521673452, hcli@regsj.dk
About this study
This nationwide, registry-based study aims to link Danish Prehospital Drowning Data data with inhospital data to develop a Utstein-style Danish Drowning Registry. This study will report mortality and neurological outcomes 30 days after a drowning incident since 2016.
Read the detailed description
Purpose
The purpose of this study is to establish recommendations towards specific educational, preventative, rescue, or treatment strategies to reduce the number of fatal and non-fatal drowning incidents in Denmark (e.g., campaigns targeting high-risk groups, or fencing, allocating rescue equipment, or establishing lifeguard stations in high-risk areas).
Objectives
The primary objective is to estimate 30-day mortality of drowning incidents in Denmark treated by the Emergency Medical Services from 2016. The secondary objective is to explore risk factors associated with 30-day mortality.
Study design
A nationwide registry-based study linking data from the Danish Prehospital Drowning Data with data from the inhospital electronic medical records. from 2016 and follow-up on mortality 30 days after the drowning incident. Neurological outcomes will be assessed by trained observers through the inhospital electronic medical records.
- Conditions
- Drowning, Drowning, Near, Drowning; Asphyxia, Drowning and Nonfatal Submersion, Drowning or Immersion of Unknown Intent, Drowning and Submersion, Undetermined Intent
- Being tested
- Drowning
- Keywords
- Danish Drowning Formula, Drowning, Danish Prehospital Drowning Data, Registry, Database, Emergency Medical Service, Utstein, Register, Epidemiology
- Medical subject headings
- Drowning, 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 by the WHO in 2002 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 have died before 30 days after the drowning incident. Receives: Other: Drowning | |
| Non-fatal drowning | This group of patients have survived until 30 days after the drowning incident. Receives: Other: Drowning |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
The patient died before 30 days after the drowning incident
Measured: 30 days after the drowning incident
Neurological outcome
Using the modified Ranking Scale (mRS) score
Measured: 30 days after the drowning incident
Secondary outcomes (6)
Hospital length of stay
Continuous
Measured: Immediately after hospital discharge
Intensive care unit admission
Binary
Measured: Immediately after hospital discharge
Intensive care unit length of stay
Continuous
Measured: Immediately after hospital discharge
Need for mechanical ventilation
Binary
Measured: Immediately after hospital discharge
Duration of mechanical ventilation
Continuous
Measured: Immediately after hospital discharge
Survival to hospital discharge
Binary
Measured: Immediately after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Jan 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prehospital Center, Region Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niklas Breindahl, Region Zealand
- Investigators
- Helle Collatz Christensen, Ass. Prof., Study director, Prehospital Center, Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334276
- Sponsor's protocol ID
- DROWN_INHOS
- Acronym
- DROWN_INHOS
- Status last verified
- Nov 2024
- First submitted
- 21 Mar 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data 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 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016
- ClinicalTrials.gov ID
- NCT06334276
- Acronym / sponsor ID
- DROWN_INHOS / DROWN_INHOS
- Conditions
- Drowning, Drowning, Near, Drowning; Asphyxia, Drowning and Nonfatal Submersion, Drowning or Immersion of Unknown Intent, Drowning and Submersion, Undetermined Intent
- Keywords
- Danish Drowning Formula, Drowning, Danish Prehospital Drowning Data, Registry, Database, Emergency Medical Service, Utstein, Register
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 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 2025 (estimated)
- First posted
- 28 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.
This nationwide, registry-based study aims to link Danish Prehospital Drowning Data data with inhospital data to develop a Utstein-style Danish Drowning Registry. This study will report mortality and neurological outcomes 30 days after a drowning incident since 2016.
Detailed description
Purpose
The purpose of this study is to establish recommendations towards specific educational, preventative, rescue, or treatment strategies to reduce the number of fatal and non-fatal drowning incidents in Denmark (e.g., campaigns targeting high-risk groups, or fencing, allocating rescue equipment, or establishing lifeguard stations in high-risk areas).
Objectives
The primary objective is to estimate 30-day mortality of drowning incidents in Denmark treated by the Emergency Medical Services from 2016. The secondary objective is to explore risk factors associated with 30-day mortality.
Study design
A nationwide registry-based study linking data from the Danish Prehospital Drowning Data with data from the inhospital electronic medical records. from 2016 and follow-up on mortality 30 days after the drowning incident. Neurological outcomes will be assessed by trained observers through the inhospital electronic medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatal drowning | – | Other: DrowningThis group of patients have died before 30 days after the drowning incident. |
| Non-fatal drowning | – | Other: DrowningThis group of patients have survived until 30 days after the drowning incident. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fatal and non-fatal drowning persons from 2016 identified in the Danish Prehospital Drowning Data.
Key inclusion criteria (2 listed)
- Drowning
- Being registered in the Danish Prehospital Drowning Data with a valid civil registration number to allow for linkage with the inhospital electronic medical records
Key exclusion criteria (4 listed)
- Obvious signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity).
- Declared dead on scene.
- A valid Do-Not-Attempt-Resuscitation order or other code status orders limiting life-sustaining therapies.
- An invalid civil registration number.
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 by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid" | Other | Fatal drowning, Non-fatal drowning |
Primary outcome
30-day mortality
Time frame: 30 days after the drowning incident
The patient died before 30 days after the drowning incident
Neurological outcome
Time frame: 30 days after the drowning incident
Using the modified Ranking Scale (mRS) score
6 secondary outcomes
Hospital length of stay
Time frame: Immediately after hospital discharge
Intensive care unit admission
Time frame: Immediately after hospital discharge
Intensive care unit length of stay
Time frame: Immediately after hospital discharge
Need for mechanical ventilation
Time frame: Immediately after hospital discharge
Duration of mechanical ventilation
Time frame: Immediately after hospital discharge
Survival to hospital discharge
Time frame: Immediately after hospital discharge
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 29 Nov 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. Data 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.
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 4 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: looking for participants now, as of the sponsor's last update on 29 Nov 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?
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?
Contact Niklas Breindahl, MD (28566410, nbrei@regsj.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (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 NCT06334276, 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 29 Nov 2024.