Clinical trial NCT06310499: Primary or Secondary Drowning
Official title: Primary or Secondary Fatal Drowning? A Registry-based Study Analysing Autopsy Reports From Patients Registered in the Danish Prehospital Drowning Data
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Drowning
Drowning; Anoxia
Drowning, Near
Drowning in Swimming Pool
Drowning; Asphyxia
Drowning/Diving/SCUBA Accident
Drowning or Immersion of Unknown Intent
Drowning and Submersion, Undetermined Intent
Drowning and Submersion While in Bath-Tub
Drowning and Submersion While in Natural Water
Drowning and Submersion Due to Sailboat Sinking
Drowning and Submersion Due to Fall Off Ship
Drowning and Submersion While in Swimming-Pool
Keywords: Drowning
Epidemiology
Danish Prehospital Drowning Data
Danish Drowning Formula
Registry
Cohort
Autopsy
Cause of death
Death certificate
Database
Denmark
Utstein
Lead sponsor: Prehospital Center, Region Zealand
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Danish Prehospital Drowning Data reports prehospital data on patients with fatal and non-fatal drowning treated by the Emergency Medical Services in Denmark since 2016. Drowning incidents are identified from the Danish Prehospital Electronic Medical Record using the Danish Drowning Formula and extensive manual validation. Data is extracted following the revised USFD. The patients' unique civil registration number enable linkage with the Civil Personal Register to obtain data on 30-day survival and differentiate between fatal and non-fatal drowning incidents

Brief summary: According to WHO's rules, any death certificate must state the underlying cause of death and contributory causes of death may also be stated.

Differentiating between primary and secondary drowning is difficult, as information preceding the drowning incident is rarely available. Yet, knowing the most frequent causes of secondary drowning may provide useful information to healthcare professionals working in prehospital Emergency Medical Services, as this may affect prehospital treatment.

Detailed description: The annual death statistics are based solely on the underlying cause of death, that is the disease or condition which started the process that led to death. The conditions that directly caused the death are also to be stated by the physician on the death certificate and may be included in the statistics. In research projects, data on those contributory causes of death may be drawn from the register. It is now the medical doctor who has verified the death and issued the death certificate indicating the underlying and contributory causes of death, who also classifies these causes in accordance with ICD-10 and fills in the coded data on the electronic death certificate. The Danish Register of Causes of Death is, thus, updated without central validation of the classification and relies entirely on the coding done by individual physicians.

This study aims to characterise fatal drowning incidents as primary or secondary drownings and report the frequencies of secondary drowning causes.

Eligibility criteria: Inclusion Criteria:

* All drowning patients registered in the Danish Prehospital Drowning Data AND
* Having a fatal outcome within 30 days after the drowning incident AND
* Having a valid civil registration number in the Danish Prehospital Drowning Data
* Being able to link data from the Danish Register of Causes of Death

Exclusion Criteria:

* Patients alive 30 days after the drowning incident
* Patients with an invalid civil registration number in the Danish Prehospital Drowning Data
* Patients where data cannot be retrieved from the Danish Register of Causes of Death

Primary outcomes:
measure: Autopsy rate
timeFrame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
measure: Primary fatal drowning rate
timeFrame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
measure: Secondary fatal drowning rate
timeFrame: Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Secondary outcomes:
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Prehospital Center
state: Region Zealand
Study officials:
affiliation: Prehospital Center, Region Zealand
name: Helle Collatz Christensen, Ass. Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Helweg-Larsen K. The Danish Register of Causes of Death. Scand J Public Health. 2011 Jul;39(7 Suppl):26-9. doi: 10.1177/1403494811399958.