Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016

NCT06334276 | Recruiting

• 1 other identifier: DROWN_INHOS
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drowning; Drowning, Near; Drowning; Asphyxia; Drowning and Nonfatal Submersion; 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 While in Swimming-Pool

Keywords

Danish Drowning Formula; Drowning; Danish Prehospital Drowning Data; Registry; Database; Emergency Medical Service; Utstein; Register; Epidemiology

Outcome Measures

Primary Outcomes (2)

• 30-day mortality

  The patient died before 30 days after the drowning incident

  30 days after the drowning incident

• Neurological outcome

  Using the modified Ranking Scale (mRS) score

  30 days after the drowning incident

Secondary Outcomes (6)

• Hospital length of stay

  Immediately after hospital discharge

• Intensive care unit admission

  Immediately after hospital discharge

• Intensive care unit length of stay

  Immediately after hospital discharge

• Need for mechanical ventilation

  Immediately after hospital discharge

• Duration of mechanical ventilation

  Immediately after hospital discharge

Study Arms (2)

Fatal drowning

This group of patients have died before 30 days after the drowning incident.

Other: Drowning

Non-fatal drowning

This group of patients have survived until 30 days after the drowning incident.

Other: Drowning

Interventions

Drowning OTHER

Drowning is defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid"

Fatal drowning; Non-fatal drowning

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fatal and non-fatal drowning persons from 2016 identified in the Danish Prehospital Drowning Data.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prehospital Center, Region Zealand: lead

Study Sites (1)

Prehospital Center Region Zealand

Næstved, Region Sjælland, 4700, Denmark

RECRUITING

Related 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.

  PMID: 37619443 BACKGROUND

MeSH Terms

Conditions

Drowning; Near Drowning; Asphyxia

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Helle Collatz Christensen, Ass. Prof.

  Prehospital Center, Region Zealand

  STUDY DIRECTOR

Central Study Contacts

Niklas Breindahl, MD

CONTACT

28566410; nbrei@regsj.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principel Investigator

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: January 1, 2016
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)