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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06310525
Other study ID # DROWN_DDF2
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Prehospital Center, Region Zealand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Danish Drowning Formula (DDF) was designed to search the unstructured text fields in the Danish nationwide Prehospital Electronic Medical Record on unrestricted terms with comprehensive search criteria to identify all potential water-related incidents and achieve a high sensitivity. This was important as drowning is a rare occurrence, but it resulted in a low Positive Predictive Value for detecting drowning incidents specifically. This study aims to augment the positive predictive value of the DDF and reduce the temporal demands associated with manual validation.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1500
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Drowning incident
Drowning was defined by the WHO in 2002 as "the process of experiencing respiratory impairment from submersion or immersion in liquid".

Locations

Country Name City State
Denmark Prehospital Center Næstved Region Zealand

Sponsors (1)

Lead Sponsor Collaborator
Prehospital Center, Region Zealand

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity of the machine learning algorithm as a drowning identification tool Sensitivity [TP / (TP+FN)] will be calculated to show the performance of the machine learning as a drowning identification tool. The sensitivity of the trained machine learning will be calculated based on data from 2022 and 2023.
Primary Specificity of the machine learning algorithm as a drowning identification tool Specificity [TN / (FP+TN)] will be calculated to show the performance of the machine learning as a drowning identification tool. The specificity of the trained machine learning will be calculated based on data from 2022 and 2023.
Primary PPV of the machine learning algorithm PPV [TP / (TP+FP)] will be calculated to show the machine learning test result. The PPV of the trained machine learning will be calculated based on data from 2022 and 2023.
Primary NPV of the machine learning algorithm NPV [TN / (FN+TN)] will be calculated to show the machine learning test result. The NPV of the trained machine learning will be calculated based on data from 2022 and 2023.
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