- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06327893
Patients Treated by the Danish Emergency Medical Services Following Non-drowning Water Rescues From 2016 to 2023 (RESCUE)
Patients Treated by the Danish Emergency Medical Services Following Non-drowning Water Rescues From 2016 to 2023: A Danish Registry-based Study From 2016 to 2023
Study Overview
Status
Conditions
- Drowning
- Drowning, Near
- Submersion
- Submersion - Accidental
- Submersion or Drowning Due to Being Washed Overboard
- Submersion or Drowning Due to Being Thrown Overboard
- Submersion or Drowning Due to Ship Sinking, Water Skier Injured
- Submersion or Drowning Due to Boat Submerging, Swimmer Injured
- Submersion or Drowning Due to Boat Overturning, Swimmer Injured
- Submersion or Drowning Due to Boat Submerging, Water Skier Injured
- Submersion or Drowning Due to Fall From Gangplank, Swimmer Injured
- Submersion or Drowning Due to Ship Sinking, Docker or Stevedore Injured
- Submersion or Drowning Due to Fall Overboard, Docker or Stevedore Injured
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Niklas Breindahl, MD, PhD
- Phone Number: 28566410
- Email: niklas.breindahl@gmail.com
Study Contact Backup
- Name: Helle Collatz Christensen, MD, PhD
- Email: Hcli@regsj.dk
Study Locations
-
-
Region Sjælland
-
Næstved, Region Sjælland, Denmark, 4700
- Recruiting
- Prehospital Center
-
Contact:
- Helle Collatz Christensen, MD, PhD
- Phone Number: 004521673452
- Email: Hcli@regsj.dk
-
Contact:
- Niklas Breindahl, MD, PhD
- Phone Number: 004528566410
- Email: niklas.breindahl@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients treated by the Danish EMS following an aquatic rescue are identified from the Danish Prehospital Electronic Medical Record using the Danish Drowning Formula and extensive manual validation.
We used the WHO definition of drowning supported by the "Clarification and Categorisation of Non-fatal Drowning" statement to differentiate between drowning and non-drowning aquatic rescues.
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Aquatic rescue
Patients treated by the Danish EMS following an aquatic rescue performed by lay or professional rescuers are identified from the Danish PEMR using the Danish Drowning Formula (DDF) and extensive manual validation.
|
The patient must have been submersed or immersed in liquid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The annual incidence.
Time Frame: From 2016 to 2023.
|
The incidence will be reported as the annual number of cases.
|
From 2016 to 2023.
|
|
The annual incidence rate.
Time Frame: From 2016 to 2023.
|
The incidence rate will be reported as the annual number of cases per 100,000 person-years.
|
From 2016 to 2023.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The spatial distribution of aquatic rescues on a map of Denmark.
Time Frame: From 2016-2023.
|
Each incident will be presented with a single entry based on the geographical coordinates of the incident.
|
From 2016-2023.
|
Collaborators and Investigators
Investigators
- Study Director: Helle Collatz Christensen, Ass. Prof., Prehospital Center, Region Zealand
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AQUATIC_RESCUE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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