DrowningDROWN_SARNCT06322134
Drowning Incidents Treated by the Danish SAR Helicopters
An observational study of Drowning and Drown, run by Prehospital Center, Region Zealand at 1 site in Denmark.
Trial summary
Improving oxygenation and ventilation in drowning patients early in the field is critical and may be lifesaving. This may be achieved by helicopter emergency medical services (HEMS) such as the Danish Air Ambulance, or the Royal Danish Air Force's Search And Rescue (SAR) helicopters. 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 incident
- How many people
- 247 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2014to 31 Oct 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: Drowning patients will be identified through manual validation of the Royal Danish Air Force's SAR helicopter's records using the internationally accepted definitions of fatal and non-fatal drowning incidents. Drowning was defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid". If the incident involved submersion or immersion, but the patient did not experience respiratory impairment, the incident was categorised as a water rescue.
Who may be able to join
- Patients treated by the Danish SAR helicopters AND
- Drowning as defined by the WHO (the process of experiencing respiratory impairment from submersion or immersion in liquid)
Who cannot join
- Patients who have not been immersed or submersed.
- Duplets.
- Interhospital transfers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Characteristics of Drowning Patients at Sea Treated by the Royal Danish Air Force's Search And Rescue Helicopters From 2014-2023: a Nationwide Registry-based Study
Improving oxygenation and ventilation in drowning patients early in the field is critical and may be lifesaving. This may be achieved by helicopter emergency medical services (HEMS) such as the Danish Air Ambulance, or the Royal Danish Air Force's Search And Rescue (SAR) helicopters. The SAR operates in all weather conditions and is equipped with a hoist system, able to hoist patients from the sea or small ships without helipads. This study aimed to estimate the incidence of drowning missions attended by the Royal Danish Air Force's SAR helicopter and describe patient characteristics and prehospital interventions.
Read the detailed description
The national Danish Drowning Cohort contains data on all fatal and non-fatal drowning patients treated by the Emergency Medical Services. However, data on drowning patients treated by the SAR helicopters is reported in a separate system.
The population of drowning patients treated by the SAR helicopters has never been described, thus contributing to the potential underreporting of the most critically ill drowning patients in Denmark. Given the rarity of drowning, registry-based studies are needed to provide patient characteristics and evaluate critical care interventions performed on this group of patients.
This study aims to identify and describe a national cohort of drowning patients at sea treated by the Royal Danish Air Force's SAR helicopters from 2014 to 2023.
- Conditions
- Drowning, Drown, Drowning; Anoxia, Drowning, Near, Drowning and Nonfatal Submersion, Drowning or Immersion of Unknown Intent
- Being tested
- Drowning incident
- Keywords
- Drowning, Danish Drowning Formula, Royal Danish Air Force, Search And Rescue (SAR), Emergency Medical Service (EMS), Registry, Retrospective, Epidemiology, Danish Prehospital Drowning Data
- Medical subject headings
- Drowning, Hypoxia, Near Drowning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drowning incidentOther
Patients categorized as drowning have been experiencing respiratory impairment from submersion or immersion in liquid and needing rescue by the Royal Danish Air Force's Search and Rescue (SAR) helicopters.
| Study group | Role | What they receive |
|---|---|---|
| Fatal drowning | Prehospital mortality following a drowning incident, defined as a dichotomous variable (dead or alive) evaluated at case termination. Patients admitted to the hospital with cardiac arrest were considered fatal drowning incidents in this study. Receives: Other: Drowning incident | |
| Non-fatal drowning | Drowning incidents where the patient had spontaneous circulation at hospital admission. Receives: Other: Drowning incident |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual incidence of drowning treated by the Danish SAR helicopters from 2014-2023
The incidence will be reported as the annual number of cases.
Measured: 1 year
Annual incidence rate of drowning treated by the Danish SAR helicopters from 2014-2023
The incidence rate as the annual number of cases per 100,000 person-years.
Measured: 1 year
Secondary outcomes (1)
Spatial distribution of drowning patients treated by the Danish SAR helicopters from 2014-2023
The spatial distribution of drowning incidents will be displayed on a map of Denmark, with each case presented with a single entry based on the geographical coordinates of the incident.
Measured: The map will display all drowning incidents treated by the Danish SAR helicopters from 2014-2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Jan 2014
- Primary completion31 Jan 2024
- Study completion31 Oct 2024
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
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prehospital Center, Region Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Defence
- 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
- NCT06322134
- Sponsor's protocol ID
- DROWN_SAR
- Acronym
- DROWN_SAR
- Status last verified
- Dec 2024
- First submitted
- 7 Mar 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or 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 37619443Breindahl 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 38448994Breindahl 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Characteristics of Drowning Patients at Sea Treated by the Royal Danish Air Force's Search And Rescue Helicopters From 2014-2023: a Nationwide Registry-based Study
- ClinicalTrials.gov ID
- NCT06322134
- Acronym / sponsor ID
- DROWN_SAR / DROWN_SAR
- Conditions
- Drowning, Drown, Drowning; Anoxia, Drowning, Near, Drowning and Nonfatal Submersion, Drowning or Immersion of Unknown Intent
- Keywords
- Drowning, Danish Drowning Formula, Royal Danish Air Force, Search And Rescue (SAR), Emergency Medical Service (EMS), Registry, Retrospective, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Prehospital Center, Region ZealandUniversity, hospital or other
- Collaborators
- Danish Defence
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 20 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.
Improving oxygenation and ventilation in drowning patients early in the field is critical and may be lifesaving. This may be achieved by helicopter emergency medical services (HEMS) such as the Danish Air Ambulance, or the Royal Danish Air Force's Search And Rescue (SAR) helicopters. The SAR operates in all weather conditions and is equipped with a hoist system, able to hoist patients from the sea or small ships without helipads. This study aimed to estimate the incidence of drowning missions attended by the Royal Danish Air Force's SAR helicopter and describe patient characteristics and prehospital interventions.
Detailed description
The national Danish Drowning Cohort contains data on all fatal and non-fatal drowning patients treated by the Emergency Medical Services. However, data on drowning patients treated by the SAR helicopters is reported in a separate system.
The population of drowning patients treated by the SAR helicopters has never been described, thus contributing to the potential underreporting of the most critically ill drowning patients in Denmark. Given the rarity of drowning, registry-based studies are needed to provide patient characteristics and evaluate critical care interventions performed on this group of patients.
This study aims to identify and describe a national cohort of drowning patients at sea treated by the Royal Danish Air Force's SAR helicopters from 2014 to 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatal drowning | – | Other: Drowning incidentPrehospital mortality following a drowning incident, defined as a dichotomous variable (dead or alive) evaluated at case termination. Patients admitted to the hospital with cardiac arrest were considered fatal drowning incidents in this study. |
| Non-fatal drowning | – | Other: Drowning incidentDrowning incidents where the patient had spontaneous circulation at hospital admission. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Drowning patients will be identified through manual validation of the Royal Danish Air Force's SAR helicopter's records using the internationally accepted definitions of fatal and non-fatal drowning incidents. Drowning was defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid". If the incident involved submersion or immersion, but the patient did not experience respiratory impairment, the incident was categorised as a water rescue.
Key inclusion criteria (2 listed)
- Patients treated by the Danish SAR helicopters AND
- Drowning as defined by the WHO (the process of experiencing respiratory impairment from submersion or immersion in liquid)
Key exclusion criteria (3 listed)
- Patients who have not been immersed or submersed.
- Duplets.
- Interhospital transfers.
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 |
|---|---|---|
| Drowning incidentPatients categorized as drowning have been experiencing respiratory impairment from submersion or immersion in liquid and needing rescue by the Royal Danish Air Force's Search and Rescue (SAR) helicopters. | Other | Fatal drowning, Non-fatal drowning |
Primary outcome
Annual incidence of drowning treated by the Danish SAR helicopters from 2014-2023
Time frame: 1 year
The incidence will be reported as the annual number of cases.
Annual incidence rate of drowning treated by the Danish SAR helicopters from 2014-2023
Time frame: 1 year
The incidence rate as the annual number of cases per 100,000 person-years.
1 secondary outcome
Spatial distribution of drowning patients treated by the Danish SAR helicopters from 2014-2023
Time frame: The map will display all drowning incidents treated by the Danish SAR helicopters from 2014-2023.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 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.
- Background: PubMed 38448994Breindahl 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.
- 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 datasets used and/or 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, 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 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 2 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: finished, as of the sponsor's last update on 4 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Annual incidence of drowning treated by the Danish SAR helicopters from 2014-2023 (time frame: 1 year). 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 NCT06322134, 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 4 Dec 2024.