- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06310525
Using Machine Learning to Optimise the Danish Drowning Formula (DROWN_DDF2)
Machine Learning-assisted Drowning Identification for the Danish Prehospital Drowning Data: Using Machine Learning to Optimise the Danish Drowning Formula
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The DDF was published in 2023. It is a text-search algorithm designed to search the unstructured text fields in databases containing electronic medical records to identify all potential water-related incidents. The DDF consists of numerous trigger words related to submersion injury (e.g., "drukn"/ drown, "vand"/water, "hav"/ocean, and "båd"/ boat).
An ongoing study showed impressive performance metrics of the DDF as a drowning identification tool when applied to the Danish PEMR on unrestricted terms. However, the PPV was low for detecting drowning incidents specifically. This study aims to augment the DDF's positive predictive value and reduce the temporal demands associated with manual validation.
Data are extracted from the Danish nationwide Prehospital Electronic Medical Record using the DDF and manually validated before entered into the Danish Prehospital Drowning Data (DPDD).
Data from the DPDD from 2016-2021 will be split into 80% (training data) and 20% (test data) and used to train the machine learning.
Data from the DPDD from 2022-2023 will be used as validation data to calculate the performance metrics for the machine learning.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Region Zealand
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Næstved, Region Zealand, Denmark, 4700
- Prehospital Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The patient must have been experiencing respiratory impairment from submersion or immersion in liquid (including persistent coughing, respiratory arrest, and unconsciousness).
- The patient must have been in contact with the Danish prehospital Emergency Medical Services.
Exclusion Criteria:
- Duplets
- Invalid civil registration number
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fatal drowning
Drowning incidents where the patient died within 30 days after the incident as a consequence of the submersion injury
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Drowning was defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid".
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Non-fatal drowning
Drowning incidents where the patient survived to 30 days
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Drowning was defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid".
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of the machine learning algorithm as a drowning identification tool
Time Frame: The sensitivity of the trained machine learning will be calculated based on data from 2022 and 2023.
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Sensitivity [TP / (TP+FN)] will be calculated to show the performance of the machine learning as a drowning identification tool.
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The sensitivity of the trained machine learning will be calculated based on data from 2022 and 2023.
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Specificity of the machine learning algorithm as a drowning identification tool
Time Frame: The specificity of the trained machine learning will be calculated based on data from 2022 and 2023.
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Specificity [TN / (FP+TN)] will be calculated to show the performance of the machine learning as a drowning identification tool.
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The specificity of the trained machine learning will be calculated based on data from 2022 and 2023.
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PPV of the machine learning algorithm
Time Frame: The PPV of the trained machine learning will be calculated based on data from 2022 and 2023.
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PPV [TP / (TP+FP)] will be calculated to show the machine learning test result.
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The PPV of the trained machine learning will be calculated based on data from 2022 and 2023.
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NPV of the machine learning algorithm
Time Frame: The NPV of the trained machine learning will be calculated based on data from 2022 and 2023.
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NPV [TN / (FN+TN)] will be calculated to show the machine learning test result.
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The NPV of the trained machine learning will be calculated based on data from 2022 and 2023.
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Collaborators and Investigators
Investigators
- Study Director: Helle Collatz Christensen, Ass. Prof., Prehospital Center, Region Zealand
Publications and helpful links
General Publications
- 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.
- 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.
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 (Actual)
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
- DROWN_DDF2
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
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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