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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06334276
Other study ID # DROWN_INHOS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2025
Est. completion date December 31, 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

This nationwide, registry-based study aims to link Danish Prehospital Drowning Data data with inhospital data to develop a Utstein-style Danish Drowning Registry. This study will report mortality and neurological outcomes 30 days after a drowning incident since 2016.


Description:

Purpose The purpose of this study is to establish recommendations towards specific educational, preventative, rescue, or treatment strategies to reduce the number of fatal and non-fatal drowning incidents in Denmark (e.g., campaigns targeting high-risk groups, or fencing, allocating rescue equipment, or establishing lifeguard stations in high-risk areas). Objectives The primary objective is to estimate 30-day mortality of drowning incidents in Denmark treated by the Emergency Medical Services from 2016. The secondary objective is to explore risk factors associated with 30-day mortality. Study design A nationwide registry-based study linking data from the Danish Prehospital Drowning Data with data from the inhospital electronic medical records. from 2016 and follow-up on mortality 30 days after the drowning incident. Neurological outcomes will be assessed by trained observers through the inhospital electronic medical records.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1500
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Drowning - Being registered in the Danish Prehospital Drowning Data with a valid civil registration number to allow for linkage with the inhospital electronic medical records Exclusion Criteria: - Obvious signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity). - Declared dead on scene. - A valid Do-Not-Attempt-Resuscitation order or other code status orders limiting life-sustaining therapies. - An invalid civil registration number.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Drowning
Drowning is defined by the WHO in 2002 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 (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 30-day mortality The patient died before 30 days after the drowning incident 30 days after the drowning incident
Primary Neurological outcome Using the modified Ranking Scale (mRS) score 30 days after the drowning incident
Secondary Hospital length of stay Continuous Immediately after hospital discharge
Secondary Intensive care unit admission Binary Immediately after hospital discharge
Secondary Intensive care unit length of stay Continuous Immediately after hospital discharge
Secondary Need for mechanical ventilation Binary Immediately after hospital discharge
Secondary Duration of mechanical ventilation Continuous Immediately after hospital discharge
Secondary Survival to hospital discharge Binary Immediately after hospital discharge
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