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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06327893
Other study ID # AQUATIC_RESCUE
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date May 1, 2025

Study information

Verified date March 2024
Source Prehospital Center, Region Zealand
Contact Niklas Breindahl, MD
Phone 28566410
Email niklas.breindahl@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Since 2015, all Danish prehospital EMS have used the nationwide Prehospital Electronic Medical Record (PEMR). In 2023, the investigators developed the Danish Drowning Formula (DDF), a text-search algorithm designed to search the unstructured text fields in the electronic medical records with comprehensive search criteria to identify all potential water-related incidents. This protocol describes the first study to analyse the prehospital data from a nationwide Danish cohort of patients treated by the EMS from 2016 to 2023 following non-drowning aquatic rescues.


Description:

Purpose The purpose of this study is to establish recommendations towards specific educational, preventative, or rescue strategies to reduce the number of aquatic rescues in Denmark (e.g., campaigns targeting high-risk groups, or fencing, allocating rescue equipment, or establishing lifeguard stations in high-risk areas). This may not only enhance prevention of aquatic rescues but also decrease the mortality and the total number of drowning incidents in Denmark. Objectives The primary objective is to estimate the yearly incidence of patients treated by the Danish EMS following a non-drowning aquatic rescue from 2016 to 2023 and calculate the aquatic rescue to drowning ratio. The secondary objectives are to characterise the rescues (e.g., lay rescuer or professional rescuer, use of equipment) and to report the spatial distribution. Study design This study is a nationwide registry-based study with data from the Danish nationwide PEMR from 2016 to 2023. Methods Since 2015, all Danish prehospital EMS have used the nationwide Prehospital Electronic Medical Record (PEMR). In 2023, the investigators developed the Danish Drowning Formula (DDF), a text-search algorithm designed to search the unstructured text fields in the electronic medical records with comprehensive search criteria to identify all potential water-related incidents. This study will be the first to analyse the prehospital data from a nationwide Danish cohort of patients treated by the EMS from 2016 to 2023 following non-drowning aquatic rescues.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3000
Est. completion date May 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All the patients registered in the Danish Prehospital Electronic Medical Record from 2016-2023 will be screened by the Danish Drowning Formula and the medical records containing one or more trigger words will be extracted for manual validation. - All records where the patient was immersed or submersed in liquid but did not experience mild, moderate, or severe respiratory impairment following the drowning process will be included. Exclusion Criteria: - All records where the patient was immersed or submersed in liquid and did experience mild, moderate, or severe respiratory impairment following the drowning process). - All records where the patient was not immersed or submersed in liquid.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Submersion or immersion in liquid
The patient must have been submersed or immersed 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 (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary The annual incidence. The incidence will be reported as the annual number of cases. From 2016 to 2023.
Primary The annual incidence rate. The incidence rate will be reported as the annual number of cases per 100,000 person-years. From 2016 to 2023.
Secondary The spatial distribution of aquatic rescues on a map of Denmark. Each incident will be presented with a single entry based on the geographical coordinates of the incident. From 2016-2023.
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