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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06322134
Other study ID # DROWN_SAR
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 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

Improving oxygenation and ventilation in drowning patients early in the field is critical and may be lifesaving. This may be achieved by helicopter emergency medical services (HEMS) such as the Danish Air Ambulance, or the Royal Danish Air Force's Search And Rescue (SAR) helicopters. The SAR operates in all weather conditions and is equipped with a hoist system, able to hoist patients from the sea or small ships without helipads. This study aimed to estimate the incidence of drowning missions attended by the Royal Danish Air Force's SAR helicopter and describe patient characteristics and prehospital interventions.


Description:

The national Danish Prehospital Drowning Data contains data on all fatal and non-fatal drowning patients treated by the Emergency Medical Services. However, data on drowning patients treated by the SAR helicopters is reported in a separate system. The population of drowning patients treated by the SAR helicopters has never been described, thus contributing to the potential underreporting of the most critically ill drowning patients in Denmark. Given the rarity of drowning, registry-based studies are needed to provide patient characteristics and evaluate critical care interventions performed on this group of patients. This study aims to identify and describe a national cohort of drowning patients at sea treated by the Royal Danish Air Force's SAR helicopters from 2014 to 2023.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
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: - Patients treated by the Danish SAR helicopters AND - Drowning as defined by the WHO (the process of experiencing respiratory impairment from submersion or immersion in liquid) OR - Water rescue defined as needing rescue following submersion or immersion in liquid without respiratory impairment. Exclusion Criteria: - Patients who have not been immersed or submersed. - Duplets. - Interhospital transfers.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Drowning incident
Patients categorized as drowning have been experiencing respiratory impairment from submersion or immersion in liquid and needing rescue by the Royal Danish Air Force's Search and Rescue (SAR) helicopters.

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 Annual incidence of drowning treated by the Danish SAR helicopters from 2014-2023 The incidence will be reported as the annual number of cases. 1 year
Primary Annual incidence rate of drowning treated by the Danish SAR helicopters from 2014-2023 The incidence rate as the annual number of cases per 100,000 person-years. 1 year
Primary Spatial distribution of drowning patients treated by the Danish SAR helicopters from 2014-2023 The spatial distribution of drowning incidents will be displayed on a map of Denmark, with each case presented with a single entry based on the geographical coordinates of the incident. The map will display all drowning incidents treated by the Danish SAR helicopters from 2014-2023.
Secondary Drowning to water rescue ratio We will report the number of drowning patients (defined by respiratory impairment) compared to patients rescued from the sea without respiratory impairment from 2014-2023. The ratio will show the cumulated frequencies from 2014-2023.
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