DrowningDROWN_CALLNCT06310486
The Emergency Call on Drowning
An observational study of Drowning and Drowning; Anoxia, run by Prehospital Center, Region Zealand at 1 site in Denmark.
Trial summary
This study aims to 1) describe patient-, setting-, and dispatcher-related characteristics in drowning-related emergency calls to the Emergency Medical Dispatch Centre (1-1-2 emergency phone) and 2) factors associated with 30-day survival. 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-related OHCA and Drowning-related non-OHCA
- 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: All validated drowning cases registered in the Danish Prehospital Drowning Data will be linked with data from the EMDC database according to a data minimisation principle. Patients are included in the Danish Prehospital Drowning Data if they have experienced a drowning incident between 2016 and 2023, defined as experiencing respiratory impairment from submersion or immersion in liquid.
Who may be able to join
- Patients at all ages registered in the Danish Prehospital Drowning Data are eligible.
Who cannot join
- Obvious clinical signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity)
- A valid Do-Not-Attempt-Resuscitation (DNAR) order or other code status orders limiting life-sustaining therapies
- Missing or corrupted audio files
- Missing identification number
- Missing 30-day survival
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, 4700
Niklas Breindahl, MD, PhD, 28566410, niklas.breindahl@gmail.com
Helle Collatz Christensen, MD, PhD, Ass. Prof., Hcli@regsj.dk
About this study
Official title: The Emergency Call on Drowning: A Registry-based Cohort Study of the Characteristics, Predictors, and Outcomes of Fatal and Non-fatal Drowning
This study aims to 1) describe patient-, setting-, and dispatcher-related characteristics in drowning-related emergency calls to the Emergency Medical Dispatch Centre (1-1-2 emergency phone) and 2) factors associated with 30-day survival. The investigators will separately analyse drowning-related out-of-hospital cardiac arrest (OHCA) and drowning-related non-OHCA. If feasible, the investigators will qualitatively analyse the calls to identify and describe potential barriers for an optimal handling strategy.
Read the detailed description
Previous studies have explored emergency priority levels, emergency call categorisations, barriers to assessing an emergency call, and the effects on the outcome. However, this has never been done specifically for drowning patients. Drowning presents a rare and special circumstance that may be particularly complex for laypeople and medical dispatchers for several reasons. Despite this complexity and medical dispatchers' potential to optimize treatment and improve outcomes in drowning incidents, the characteristics of drowning-related emergency calls have never been explored.
This protocol presents a registry-based cohort study of drowning-related emergency medical calls to the EMDC (1-1-2 emergency phone) with 30-day follow-up.
Data from the national Danish Prehospital Drowning Data will be linked with audio files and electronic data from the EMDC database using the patient's unique civil registration numbers.
The investigators will construct two lists of variables: one list for OHCA and one for non-OHCA emergency calls. Data collection from the EMDC database will consist of three phases.
In phase 1, three independent reviewers will listen to 20 emergency calls on drowning (10 OHCA and 10 non-OHCA) to identify relevant variables from the calls (e.g., presence of key symptoms [since an emergency call often does not contain information regarding the absence of symptoms], communication barriers [anything that comes in the way of receiving and understanding information], pre-arrival instructions to callers etc.).
In phase 2, the same reviewers will listen to 20 other emergency calls (10 OHCA and 10 non-OHCA) and use the lists for data collection to determine the data availability and completeness. This may result in modifications to the lists of variables. The investigators will use the results as a basis for reviewer training and calculate inter-rater reliability.
Once the reviewers' performances are satisfying (defined as Fleiss kappa ≥0.8), the investigators will move to phase 3 and collect data for all the drowning calls. Emergency calls will be stratified as OHCA or non-OHCA calls.
- Conditions
- Drowning, Drowning; Anoxia, Drowning, Near, Drowning; Asphyxia, Drowning and Nonfatal Submersion, Drowning or Immersion of Unknown Intent
- Being tested
- Drowning-related OHCA, Drowning-related non-OHCA
- Keywords
- Emergency Medical Service (EMS), Drowning, Emergency Medical Dispatch Centre, Emergency Medical Coordination Centre, Dispatch, Emergency Call, Registry, Database, Epidemiology, Danish Drowning Formula, Danish Prehospital Drowning Data, 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.
Drowning-related OHCAOther
These patients were involved in a drowning incident (submersion or immersion in liquid) and experienced out-of-hospital cardiac arrest (OHCA), defined as being unconscious and not breathing normally at any time in the prehospital setting. Some of these patients may die as a consequence of the submersion injury (fatal drowning), while others may survive (non-fatal drowning).
Drowning-related non-OHCAOther
These patients were involved in a drowning incident (submersion or immersion in liquid) but did not experience an OHCA. Some of these patients may die as a consequence of the submersion injury (fatal drowning), while others may survive (non-fatal drowning).
| Study group | Role | What they receive |
|---|---|---|
| Fatal drowning | These patients experienced a drowning incident and died within 30 days after the incident because of their submersion injury. Receives: Other: Drowning-related OHCA; Other: Drowning-related non-OHCA | |
| Non-fatal drowning | These patients experienced a drowning incident and survived until 30 days after the incident. Receives: Other: Drowning-related OHCA; Other: Drowning-related non-OHCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-related characteristics influencing the 30-day survival
Describe patient-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
Measured: 30 days after the drowning incident
Setting-related characteristics influencing the 30-day survival
Describe setting-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
Measured: 30 days after the drowning incident
Caller-related characteristics influencing the 30-day survival
Describe caller-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
Measured: 30 days after the drowning incident
Dispatcher-related characteristics influencing the 30-day survival
Describe dispatcher-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
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 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 (2)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, Prehospital Center, Region Zealand
- Investigators
- Helle Collatz Christensen, MD, PhD, Ass. Prof., Study director, Prehospital Center, Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310486
- Sponsor's protocol ID
- DROWN_CALL
- Acronym
- DROWN_CALL
- Status last verified
- Jun 2025
- First submitted
- 7 Mar 2024
- Last updated
- 4 Jun 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 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 38448994
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Emergency Call on Drowning: A Registry-based Cohort Study of the Characteristics, Predictors, and Outcomes of Fatal and Non-fatal Drowning
- ClinicalTrials.gov ID
- NCT06310486
- Acronym / sponsor ID
- DROWN_CALL / DROWN_CALL
- Conditions
- Drowning, Drowning; Anoxia, Drowning, Near, Drowning; Asphyxia, Drowning and Nonfatal Submersion, Drowning or Immersion of Unknown Intent
- Keywords
- Emergency Medical Service (EMS), Drowning, Emergency Medical Dispatch Centre, Emergency Medical Coordination Centre, Dispatch, Emergency Call, Registry, Database
- 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
- 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.
This study aims to 1) describe patient-, setting-, and dispatcher-related characteristics in drowning-related emergency calls to the Emergency Medical Dispatch Centre (1-1-2 emergency phone) and 2) factors associated with 30-day survival. The investigators will separately analyse drowning-related out-of-hospital cardiac arrest (OHCA) and drowning-related non-OHCA. If feasible, the investigators will qualitatively analyse the calls to identify and describe potential barriers for an optimal handling strategy.
Detailed description
Previous studies have explored emergency priority levels, emergency call categorisations, barriers to assessing an emergency call, and the effects on the outcome. However, this has never been done specifically for drowning patients. Drowning presents a rare and special circumstance that may be particularly complex for laypeople and medical dispatchers for several reasons. Despite this complexity and medical dispatchers' potential to optimize treatment and improve outcomes in drowning incidents, the characteristics of drowning-related emergency calls have never been explored.
This protocol presents a registry-based cohort study of drowning-related emergency medical calls to the EMDC (1-1-2 emergency phone) with 30-day follow-up.
Data from the national Danish Prehospital Drowning Data will be linked with audio files and electronic data from the EMDC database using the patient's unique civil registration numbers.
The investigators will construct two lists of variables: one list for OHCA and one for non-OHCA emergency calls. Data collection from the EMDC database will consist of three phases.
In phase 1, three independent reviewers will listen to 20 emergency calls on drowning (10 OHCA and 10 non-OHCA) to identify relevant variables from the calls (e.g., presence of key symptoms [since an emergency call often does not contain information regarding the absence of symptoms], communication barriers [anything that comes in the way of receiving and understanding information], pre-arrival instructions to callers etc.).
In phase 2, the same reviewers will listen to 20 other emergency calls (10 OHCA and 10 non-OHCA) and use the lists for data collection to determine the data availability and completeness. This may result in modifications to the lists of variables. The investigators will use the results as a basis for reviewer training and calculate inter-rater reliability.
Once the reviewers' performances are satisfying (defined as Fleiss kappa ≥0.8), the investigators will move to phase 3 and collect data for all the drowning calls. Emergency calls will be stratified as OHCA or non-OHCA calls.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatal drowning | – | Other: Drowning-related OHCA, Other: Drowning-related non-OHCAThese patients experienced a drowning incident and died within 30 days after the incident because of their submersion injury. |
| Non-fatal drowning | – | Other: Drowning-related OHCA, Other: Drowning-related non-OHCAThese patients experienced a drowning incident 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
- All validated drowning cases registered in the Danish Prehospital Drowning Data will be linked with data from the EMDC database according to a data minimisation principle. Patients are included in the Danish Prehospital Drowning Data if they have experienced a drowning incident between 2016 and 2023, defined as experiencing respiratory impairment from submersion or immersion in liquid.
Key inclusion criteria (1 listed)
- Patients at all ages registered in the Danish Prehospital Drowning Data are eligible.
Key exclusion criteria (5 listed)
- Obvious clinical signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity)
- A valid Do-Not-Attempt-Resuscitation (DNAR) order or other code status orders limiting life-sustaining therapies
- Missing or corrupted audio files
- Missing identification number
- Missing 30-day survival
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-related OHCAThese patients were involved in a drowning incident (submersion or immersion in liquid) and experienced out-of-hospital cardiac arrest (OHCA), defined as being unconscious and not breathing normally at any time in the prehospital setting. Some of these patients may die as a consequence of the submersion injury (fatal drowning), while others may survive (non-fatal drowning). | Other | Fatal drowning, Non-fatal drowning |
| Drowning-related non-OHCAThese patients were involved in a drowning incident (submersion or immersion in liquid) but did not experience an OHCA. Some of these patients may die as a consequence of the submersion injury (fatal drowning), while others may survive (non-fatal drowning). | Other | Fatal drowning, Non-fatal drowning |
Primary outcome
Patient-related characteristics influencing the 30-day survival
Time frame: 30 days after the drowning incident
Describe patient-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
Setting-related characteristics influencing the 30-day survival
Time frame: 30 days after the drowning incident
Describe setting-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
Caller-related characteristics influencing the 30-day survival
Time frame: 30 days after the drowning incident
Describe caller-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
Dispatcher-related characteristics influencing the 30-day survival
Time frame: 30 days after the drowning incident
Describe dispatcher-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
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 4 Jun 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 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.
- 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.
Helle Collatz Christensen, MD, PhD, 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 1 inclusion and 5 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 4 Jun 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?
Contact Niklas Breindahl, MD, PhD (+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?
Patient-related characteristics influencing the 30-day survival (time frame: 30 days after the drowning incident). The study lists 4 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 NCT06310486, which also lists 2 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 Jun 2025.