The Emergency Call on Drowning (DROWN_CALL)

March 13, 2024 updated by: Niklas Breindahl, Prehospital Center, Region Zealand

The Emergency Call on Drowning: A Registry-based Cohort Study of the Characteristics, Predictors, and Outcomes of Fatal and Non-fatal Drowning

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Region Zealand
      • Næstved, Region Zealand, Denmark, 4700
        • Prehospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fatal drowning
These patients experienced a drowning incident and died within 30 days after the incident because of their submersion injury.
Other: Drowning-related OHCA
These patients were involved in a drowning incident (submersion or immersion in liquid) and experienced out-of-hospital cardiac arrest (OHCA), defined as being unconscious and not breathing normally at any time in the prehospital setting. Some of these patients may die as a consequence of the submersion injury (fatal drowning), while others may survive (non-fatal drowning).
Other: Drowning-related non-OHCA
These patients were involved in a drowning incident (submersion or immersion in liquid) but did not experience an OHCA. Some of these patients may die as a consequence of the submersion injury (fatal drowning), while others may survive (non-fatal drowning).
Non-fatal drowning
These patients experienced a drowning incident and survived until 30 days after the incident.
Other: Drowning-related OHCA
These patients were involved in a drowning incident (submersion or immersion in liquid) and experienced out-of-hospital cardiac arrest (OHCA), defined as being unconscious and not breathing normally at any time in the prehospital setting. Some of these patients may die as a consequence of the submersion injury (fatal drowning), while others may survive (non-fatal drowning).
Other: Drowning-related non-OHCA
These patients were involved in a drowning incident (submersion or immersion in liquid) but did not experience an OHCA. Some of these patients may die as a consequence of the submersion injury (fatal drowning), while others may survive (non-fatal drowning).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-related characteristics influencing the 30-day survival
Time Frame: 30 days after the drowning incident
Describe patient-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
30 days after the drowning incident
Setting-related characteristics influencing the 30-day survival
Time Frame: 30 days after the drowning incident
Describe setting-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
30 days after the drowning incident
Caller-related characteristics influencing the 30-day survival
Time Frame: 30 days after the drowning incident
Describe caller-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
30 days after the drowning incident
Dispatcher-related characteristics influencing the 30-day survival
Time Frame: 30 days after the drowning incident
Describe dispatcher-related characteristics in drowning-related emergency calls to the EMDC (1-1-2 emergency phone)
30 days after the drowning incident

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prehospital Center, Region Zealand

Investigators

  • Study Director: He Collatz Christensen, Ass. Prof., Prehospital Center, Region Zealand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DROWN_CALL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and analysed during the current study are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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