Clinical trial NCT06310486: The Emergency Call on Drowning
Official title: The Emergency Call on Drowning: A Registry-based Cohort Study of the Characteristics, Predictors, and Outcomes of Fatal and Non-fatal Drowning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drowning
Drowning; Anoxia
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 Due to Sailboat Sinking
Drowning and Submersion Due to Fall Off Ship
Drowning and Submersion While in Swimming-Pool
Keywords: Emergency Medical Service (EMS)
Drowning
Emergency Medical Dispatch Centre
Emergency Medical Coordination Centre
Dispatch
Emergency Call
Registry
Database
Epidemiology
Danish Drowning Formula
Danish Prehospital Drowning Data
Utstein
Lead sponsor: Prehospital Center, Region Zealand
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All validated drowning cases registered in the Danish Prehospital Drowning Data will be linked with data from the EMDC database according to a data minimisation principle. Patients are included in the Danish Prehospital Drowning Data if they have experienced a drowning incident between 2016 and 2023, defined as experiencing respiratory impairment from submersion or immersion in liquid.

Brief summary: This study aims to 1) describe patient-, setting-, and dispatcher-related characteristics in drowning-related emergency calls to the Emergency Medical Dispatch Centre (1-1-2 emergency phone) and 2) factors associated with 30-day survival. The investigators will separately analyse drowning-related out-of-hospital cardiac arrest (OHCA) and drowning-related non-OHCA. If feasible, the investigators will qualitatively analyse the calls to identify and describe potential barriers for an optimal handling strategy.

Detailed description: Previous studies have explored emergency priority levels, emergency call categorisations, barriers to assessing an emergency call, and the effects on the outcome. However, this has never been done specifically for drowning patients. Drowning presents a rare and special circumstance that may be particularly complex for laypeople and medical dispatchers for several reasons. Despite this complexity and medical dispatchers' potential to optimize treatment and improve outcomes in drowning incidents, the characteristics of drowning-related emergency calls have never been explored.

This protocol presents a registry-based cohort study of drowning-related emergency medical calls to the EMDC (1-1-2 emergency phone) with 30-day follow-up.

Data from the national Danish Prehospital Drowning Data will be linked with audio files and electronic data from the EMDC database using the patient's unique civil registration numbers.

The investigators will construct two lists of variables: one list for OHCA and one for non-OHCA emergency calls. Data collection from the EMDC database will consist of three phases.

In phase 1, three independent reviewers will listen to 20 emergency calls on drowning (10 OHCA and 10 non-OHCA) to identify relevant variables from the calls (e.g., presence of key symptoms \[since an emergency call often does not contain information regarding the absence of symptoms\], communication barriers \[anything that comes in the way of receiving and understanding information\], pre-arrival instructions to callers etc.).

In phase 2, the same reviewers will listen to 20 other emergency calls (10 OHCA and 10 non-OHCA) and use the lists for data collection to determine the data availability and completeness. This may result in modifications to the lists of variables. The investigators will use the results as a basis for reviewer training and calculate inter-rater reliability.

Once the reviewers' performances are satisfying (defined as Fleiss kappa ≥0.8), the investigators will move to phase 3 and collect data for all the drowning calls. Emergency calls will be stratified as OHCA or non-OHCA calls.

Eligibility criteria: Inclusion Criteria:

* Patients at all ages registered in the Danish Prehospital Drowning Data are eligible.

Exclusion Criteria:

* Obvious clinical signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity)
* A valid Do-Not-Attempt-Resuscitation (DNAR) order or other code status orders limiting life-sustaining therapies
* Missing or corrupted audio files
* Missing identification number
* Missing 30-day survival

Primary outcomes:
measure: Patient-related characteristics influencing the 30-day survival
timeFrame: 30 days after the drowning incident
measure: Setting-related characteristics influencing the 30-day survival
timeFrame: 30 days after the drowning incident
measure: Caller-related characteristics influencing the 30-day survival
timeFrame: 30 days after the drowning incident
measure: Dispatcher-related characteristics influencing the 30-day survival
timeFrame: 30 days after the drowning incident
Secondary outcomes:
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Prehospital Center Region Zealand
Study officials:
affiliation: Prehospital Center, Region Zealand
name: Helle Collatz Christensen, MD, PhD, Ass. Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Breindahl N, Wolthers SA, Moller TP, Blomberg SNF, Steinmetz J, Christensen HC; Danish Drowning Validation Group. Characteristics and critical care interventions in drowning patients treated by the Danish Air Ambulance from 2016 to 2021: a nationwide registry-based study with 30-day follow-up. Scand J Trauma Resusc Emerg Med. 2024 Mar 6;32(1):17. doi: 10.1186/s13049-024-01189-y.