Primary or Secondary Drowning

Drowning Clinical Trial

— DROWN_COD  

Official title:

Primary or Secondary Fatal Drowning? A Registry-based Study Analysing Autopsy Reports From Patients Registered in the Danish Prehospital Drowning Data

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310499
• Other study ID #: DROWN_COD
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Prehospital Center, Region Zealand
• Contact: Niklas Breindahl, MD
• Phone: +4528566410
• Email: niklas.breindahl[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Drowning
• Drowning; Anoxia

Intervention

Other:
• Drowning
Drowning is defined as the process of experiencing respiratory impairment from submersion or immersion in liquid.

Locations

Country	Name	City	State
Denmark	Prehospital Center	Næstved	Region Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Prehospital Center, Region Zealand

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autopsy rate	Calculated as the number of autopsy reports divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.	Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Primary	Primary fatal drowning rate	Calculated as the number of autopsy reports stating drowning as the underlying cause of death divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.	Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.
Primary	Secondary fatal drowning rate	Calculated as the number of autopsy reports stating drowning as the contributory cause of death OR not stating drowning as a contributory cause of death divided by the number of fatal drowning incidents registered in the Danish Prehospital Drowning Data.	Data is extracted on patients registered in the Danish Prehospital Drowning Data from 2016-2023.