AzTrials
AzTrials

DrowningNCT05323097

Drowning-related OHCA in Denmark: A Six-year Registry-based Study

An observational study of Drowning and Out-Of-Hospital Cardiac Arrest, run by Prehospital Center, Region Zealand at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Within a six-year period from 2016-2021, this retrospective cohort study aims to: 1) report the national incidence of drowning related OHCA's among cases attended by the Danish Emergency Medical Services (EMS), 2) assess survival defined as return of spontaneous circulation (ROSC) on scene, by hospital admission and… Read more about this study

Who is it for?
Any age
Conditions the study is for
Drowning, Out-Of-Hospital Cardiac Arrest
What is being tested?
Drowning-related OHCA
How many people
31,200 participants
Where
1 siteDenmark
Study dates
1 Jan 2016to 31 Mar 2021
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: All Danish citizens with out-of-hospital cardiac arrest in the period from 2016-2021.

Who may be able to join

  • Out-of-hospital cardiac arrest (OHCA)

Who cannot join

  • Obvious clinical signs of irreversible death (decapitation, decomposition, postmortem lividity, postmortem rigidity)

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Prehospital Center

    Næstved, Region Sjælland, 4700

Other trials in Denmark

About this study

Official title: Drowning-related Out-of-hospital Cardiac Arrest in Denmark: A Six-year Registry-based Study

Within a six-year period from 2016-2021, this retrospective cohort study aims to: 1) report the national incidence of drowning related OHCA's among cases attended by the Danish Emergency Medical Services (EMS), 2) assess survival defined as return of spontaneous circulation (ROSC) on scene, by hospital admission and 30-day survival.

Furthermore, aspects associated with better outcome are evaluated including actions taken by EMS-personnel and laypersons, geographical localization, type of activity, witnessed event, EMS response times, bystander CPR, initial rhythm, use of defibrillator, airway devices, pre-hospital medication, and patient demographics.

This can potentially result in recommendations towards certain educative, preventative, rescue, or treatment strategies to reduce OHCA from drowning.

Read the detailed description

Introduction

Preventing drowning accidents is of great interest, as a large proportion of drowning events can be avoided by proper educative and targeted preventive measures. Yet, effective educative, preventative, rescue and treatment interventions to reduce fatal drowning events require accurate, reliable and sufficient data to be scientifically analysed. However, the complexity of the disease, various drowning terminology, definitions, and an inappropriate classification of drowning events even in high-income countries possess a great challenge when trying to gather sufficient data.

Currently, drowning is a major cause of mortality worldwide, and a leading cause of cardiac arrest in children and adolescents. Even in highly developed countries, the incidence of drowning is highest among children less than 5 years of age and in young adults between 15 and 24 years of age. The duration of submersion plays a key role in determining the outcome from drowning, as submersion exceeding 10 minutes is associated with poor outcome. Furthermore, drowning leading to hypoxic cardiac arrest is a reversible cause that can be treated. Therefore, bystanders, trained rescuers (e.g., trained lifeguards) and EMS personnel play a critical role in the initial attempts at rescue and resuscitation to prioritize oxygenation and ventilation.

Yet, research on out-of-hospital cardiac arrest (OHCA) due to drowning is limited, and under reporting contributes significantly to misunderstanding of the process of drowning. This leads to a potential for improvement, which requires first and foremost clarification of the most obvious causes and risk factors associated with OHCA from drowning following recommended guidelines for uniform reporting of data from drowning.

Thus, within a six-year period, this study aims to: 1) report the national incidence of drowning related OHCA's among cases attended by the Danish Emergency Medical Services (EMS), 2) to assess survival defined as return of spontaneous circulation (ROSC) at any time followed by status at admission and 30-day survival.

Furthermore, aspects associated with better outcome are evaluated including actions taken by EMS-personnel and laypersons, geographical localization, type of activity, witnessed event, EMS response times, bystander CPR, initial rhythm, use of defibrillator, airway devices, pre-hospital medication, and patient demographics.

This can potentially result in recommendations towards certain educative, preventative, rescue, or treatment strategies to reduce OHCA from drowning.

Methods

Terminology: Drowning is defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid". Submersion is the situation where the victim's entire body, including the airway, goes below the surface of the liquid. Immersion is to be covered in water, and for drowning to occur, usually at least the face and airway are immersed. If the victim is rescued at any time, the process of drowning is interrupted, which is termed a nonfatal drowning. If the person dies at any time because of drowning, this is termed a fatal drowning. Any submersion or immersion event without evidence of respiratory impairment is considered a water rescue and not a drowning. Terms such as "near drowning", "dry or wet drowning", "secondary drowning", "active and passive drowning", and "delayed onset of respiratory distress" should be avoided.

Setting: In 2016 the Danish Emergency Medical Services (EMS) introduced a nationwide electronic medical reporting system recording all following cases of OHCA in which a resuscitative attempt was initiated in the Danish Cardiac Arrest Registry. Together with a manual validation process, this electronic system is the cornerstone in the Danish out-of-hospital cardiac arrest (OHCA) registry, a solid base for identification and verification of OHCA. Because of the changeover a validation team manually processed all records extracted from the electronic medical records. This ensured high-quality data from the approximately 5,400 annually registered OHCA in Denmark, within the period from 2016 to 2018. From the direct registration and later manual verification, several additional data sources were coupled with each registered OHCA (e.g., survival, initiation of bystander CPR and potential drowning accident).

This enables the possibility for advanced text searching in the entire pre-hospital medical record for cases with OHCA. In a pilot-study performed at Zealand EMS in 2019, a feasible and efficient method for identifying OHCA from foreign body airway obstruction was developed, based on identification of trigger-words in the electronic medical record.

Identification of fatal drowning accidents: During the manual validation of OHCA in the changeover period, 211 cases were flagged as drowning accidents. However, the obstacle of manual verification across EMS regions persists and further data cleansing and revised search-strings are needed to provide high-quality data. Therefore, the investigators will identify trigger-words in the 211 electronic reports from the initial screening by manually reading through the medical records. A text-string based on these trigger-words will be structured and fed into a text-search algorithm able to search note-fields within the electronic medical records. When searching the electronic medical records from the OHCA register, the algorithm will return several records, consisting of OHCA presumably caused by drowning. However, the initial search alone will miss some of the manually registered OHCA caused by drowning and conversely, non-fatal drowning accidents not registered in the Danish Cardiac Arrest Registry will also be identified from the search, which need to be excluded in this research project. After a manual review of the specified reports, new trigger-words will be added to the search-string to include reports not identified during the initial manual registration ultimately leading to a revised text-string. This iterative process will be performed until no new reports appear, and the investigators will have identified the final number of OHCA presumably caused by drowning. The remaining four regions have all pledged data permission and agreed to initiate the study when funding has been acquired.

Perspectives: This study provides novel information regarding OHCA related to drowning; the descriptive statistics provides relevant data based on a reviewed, high-quality database. Furthermore, this study will enable targeted campaigns aimed at increasing survival from OHCA caused by drowning, targeting preventative actions in means of educating the public, creating awareness, increasing signage and potentially allocating lifeguards to high-risk areas, or establishing public lifeguard training and bystander initiatives.

Being tested
Drowning-related OHCA
Keywords
Drowning, Out-Of-Hospital Cardiac Arrest, Water, Register study, Retrospective
Medical subject headings
Drowning, Out-of-Hospital Cardiac Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drowning-related OHCAOther

    Drowning-related out-of-hospital cardiac arrest (OHCA): YES

Study groups in NCT05323097
Study groupRoleWhat they receive
Drowning-related OHCADrowning-related OHCA: YES
Receives: Other: Drowning-related OHCA
All other OHCADrowning-related OHCA: NO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day survival

    Alive or Dead 30 days after the event.

    Measured: 30-day after OHCA

Secondary outcomes (3)
  1. Annual incidence and survival rates of drowning-related OHCA per 100,000 from 2016-2021

    Stratified by the most obvious causes and risk factors following recommended guidelines for uniform reporting of data from drowning including precipitating event, geographical localization, and type of activity

    Measured: Annually from 2016-2021 (at the end of the year)

  2. Map of drowning-related OHCA in Denmark from 2016-2021

    Showing a map of geographical localization of drowning-related OHCA in Denmark in the study period indicating 30-day mortality and survival

    Measured: 5-year period from 2016-2021

  3. Survival status at hospital admission

    ROSC (unconscious) at hospital admission, ROSC (conscious) at hospital admission, Ongoing CPR at hospital admission, Dead at hospital admission

    Measured: At hospital admission within 24 hours after admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start1 Jan 2016
  3. Primary completion31 Jan 2021
  4. Study completion31 Mar 2021

Resources

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
31,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05323097
Sponsor's protocol ID
DROWN_OHCA
Status last verified
Mar 2024
First submitted
25 Mar 2022
Last updated
25 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The study protocol and statistical analysis plan are available in Danish from the corresponding author upon request.

Publications

  • Weiss J; American Academy of Pediatrics Committee on Injury, Violence, and Poison Prevention. Prevention of drowning. Pediatrics. 2010 Jul;126(1):e253-62. doi: 10.1542/peds.2010-1265. Epub 2010 May 24.

    PubMed 20498167
  • Schmidt AC, Sempsrott JR, Szpilman D, Queiroga AC, Davison MS, Zeigler RJ, McAlister SJ. The use of non-uniform drowning terminology: a follow-up study. Scand J Trauma Resusc Emerg Med. 2017 Jul 17;25(1):72. doi: 10.1186/s13049-017-0405-x.

    PubMed 28716063
  • Papa L, Hoelle R, Idris A. Systematic review of definitions for drowning incidents. Resuscitation. 2005 Jun;65(3):255-64. doi: 10.1016/j.resuscitation.2004.11.030.

    PubMed 15919561
  • Lu TH, Lunetta P, Walker S. Quality of cause-of-death reporting using ICD-10 drowning codes: a descriptive study of 69 countries. BMC Med Res Methodol. 2010 Apr 8;10:30. doi: 10.1186/1471-2288-10-30.

    PubMed 20374660
  • Steensberg J. Epidemiology of accidental drowning in Denmark 1989-1993. Accid Anal Prev. 1998 Nov;30(6):755-62. doi: 10.1016/s0001-4575(98)00028-1.

    PubMed 9805518
  • Mackie IJ. Patterns of drowning in Australia, 1992-1997. Med J Aust. 1999 Dec 6-20;171(11-12):587-90. doi: 10.5694/j.1326-5377.1999.tb123808.x.

    PubMed 10721338
  • Truhlar A, Deakin CD, Soar J, Khalifa GE, Alfonzo A, Bierens JJ, Brattebo G, Brugger H, Dunning J, Hunyadi-Anticevic S, Koster RW, Lockey DJ, Lott C, Paal P, Perkins GD, Sandroni C, Thies KC, Zideman DA, Nolan JP; Cardiac arrest in special circumstances section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 4. Cardiac arrest in special circumstances. Resuscitation. 2015 Oct;95:148-201. doi: 10.1016/j.resuscitation.2015.07.017. Epub 2015 Oct 15. No abstract available.

    PubMed 26477412
  • Venema AM, Groothoff JW, Bierens JJ. The role of bystanders during rescue and resuscitation of drowning victims. Resuscitation. 2010 Apr;81(4):434-9. doi: 10.1016/j.resuscitation.2010.01.005. Epub 2010 Feb 10.

    PubMed 20149515
  • Idris AH, Berg RA, Bierens J, Bossaert L, Branche CM, Gabrielli A, Graves SA, Handley AJ, Hoelle R, Morley PT, Papa L, Pepe PE, Quan L, Szpilman D, Wigginton JG, Modell JH; American Heart Association. Recommended guidelines for uniform reporting of data from drowning: the "Utstein style". Circulation. 2003 Nov 18;108(20):2565-74. doi: 10.1161/01.CIR.0000099581.70012.68. No abstract available.

    PubMed 14623794
  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Drowning and Out-Of-Hospital Cardiac Arrest, 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 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: finished, 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?

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?

30-day survival (time frame: 30-day after OHCA). 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 NCT05323097, which also lists 10 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 25 Mar 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in