Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT06312202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drowning Incidents in Danish Harbours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004332', 'term': 'Drowning'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D015701', 'term': 'Near Drowning'}, {'id': 'D001237', 'term': 'Asphyxia'}], 'ancestors': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yearly incidence of drowning incidents', 'timeFrame': '30 days after the drowning incident', 'description': 'Yearly incidence of fatal and non-fatal drowning incidents in Danish harbours treated by the EMS from 2016-2023'}, {'measure': 'Fatal to non-fatal drowning ratio', 'timeFrame': '30 days after the drowning incident', 'description': 'Cumulated counts of fatal to non-fatal drowning incidents from 2016-2023'}], 'secondaryOutcomes': [{'measure': 'Assess risk factors associated with 30-day mortality', 'timeFrame': '30 days after the drowning incident', 'description': 'Hypothesis-driven assessment of risk factors associated with drowning-related 30-day mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Danish Drowning Formula', 'Danish Prehospital Drowning Data', 'Denmark', 'Registry', 'Database', 'Cohort', 'Drowning', 'Harbour', 'Emergency Medical Service', 'Submersion'], 'conditions': ['Drowning', 'Drown', '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 Natural Water', 'Drowning and Submersion Due to Sailboat Sinking', 'Drowning and Submersion Due to Fall Off Ship']}, 'referencesModule': {'references': [{'pmid': '37619443', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'A recent study reported significantly increased mortality from drowning-related out-of-hospital cardiac arrest in Danish harbours compared to other public places (e.g., public pools, coastlines, and lakes). Accurate and reliable data are necessary before establishing specific educational, preventative, rescue, or treatment strategies to reduce the number of drowning incidents in Danish harbours and improve survival. Therefore, it is essential to characterise drowning incidents in Danish harbours and analyse risk factors associated with fatal drowning.', 'detailedDescription': 'Based on the GPS coordinates and advanced text-searching, it is possible to identify drowning incidents in Danish harbours and extract data from the Danish Prehospital Drowning Data.\n\nThis study is a nationwide registry-based study with data from the Danish Prehospital Drowning Data from 2016 to 2023. In this study, we will use 30-day mortality to differentiate between fatal and non-fatal drowning.\n\nThe primary objective is to estimate the yearly incidence of fatal and non-fatal drowning incidents in Danish harbours treated by the EMS from 2016 to 2023 and calculate the fatal to non-fatal ratio. The secondary objective is to assess risk factors associated with 30-day mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target condition in this study is drowning, irrespective of follow-up at 30 days (fatal or non-fatal). We used the WHO definition of drowning supported by the clarification statement for non-fatal drowning as the case definition to identify drowning (target condition) during the manual validation.\n\nThe study unit is the individual drowning patient. The target population are all fatal and non-fatal drowning patients in Danish harbours treated by the EMS in Denmark since 2016. Due to the comprehensive search criteria in the Danish Drowning Formula, it is reasonable to believe that the target population is identical to the study population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients registered in the Danish Prehospital Drowning Data from 2016-2023 will be assessed for inclusion AND\n* Incidents registered at GPS coordinates corresponding to a Danish harbour OR\n* Incidents identified using advanced text-search algorithm searching for "harbour"-related words\n\nExclusion Criteria:\n\n* Patients without a 30-day follow-up (e.g., due to missing or invalid civil registration numbers) and patients with a valid DNAR code will be excluded from the mortality analysis.'}, 'identificationModule': {'nctId': 'NCT06312202', 'acronym': 'DROWN_HARBOR', 'briefTitle': 'Drowning Incidents in Danish Harbours', 'organization': {'class': 'OTHER', 'fullName': 'Prehospital Center, Region Zealand'}, 'officialTitle': 'Fatal and Non-fatal Drowning Incidents in Danish Harbours: a Nationwide Registry-based Study Using the Danish Prehospital Drowning Data From 2016-2023', 'orgStudyIdInfo': {'id': 'DROWN_HARBOUR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fatal drowning', 'description': 'This group of patients experienced a drowning incident defined as the process of experiencing respiratory impairment from submersion or immersion in liquid and died within 30 days after the incident as a consequence of the submersion injury.', 'interventionNames': ['Other: Drowning']}, {'label': 'Non-fatal drowning', 'description': 'This group of patients experienced a drowning incident defined as the process of experiencing respiratory impairment from submersion or immersion in liquid and survived until 30 days after the incident.', 'interventionNames': ['Other: Drowning']}], 'interventions': [{'name': 'Drowning', 'type': 'OTHER', 'description': 'Drowning is defined as the process of experiencing respiratory impairment from submersion or immersion in liquid.', 'armGroupLabels': ['Fatal drowning', 'Non-fatal drowning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4700', 'city': 'Næstved', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Prehospital Center', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}], 'centralContacts': [{'name': 'Niklas Breindahl, MD', 'role': 'CONTACT', 'email': 'niklas.breindahl@gmail.com', 'phone': '+4528566410'}], 'overallOfficials': [{'name': 'Helle Collatz Christensen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'pre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets used and analysed during the current study are available from the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prehospital Center, Region Zealand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Niklas Breindahl', 'investigatorAffiliation': 'Prehospital Center, Region Zealand'}}}}