Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310486
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-07
Brief Title:
The Emergency Call on Drowning
Sponsor:
Prehospital Center Region Zealand
Organization:
Prehospital Center Region Zealand
Study Overview
Official Title:
The Emergency Call on Drowning A Registry-based Cohort Study of the Characteristics Predictors and Outcomes of Fatal and Non-fatal Drowning
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DROWN_CALL
Brief Summary:
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
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 patients 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 eg 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 08 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
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 patients 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 eg 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 08 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None