Machine Learning Assisted Recognition of Out-of-Hospital Cardiac Arrest During Emergency Calls.
Primary Purpose
Out-Of-Hospital Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Alert on dispatchers screen 'Suspect cardiac arrest'
Sponsored by
About this trial
This is an interventional diagnostic trial for Out-Of-Hospital Cardiac Arrest focused on measuring Machine learning, Artificial intelligence, Dispatcher assisted telephone CPR, Heart Arrest, Heart Diseases, Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria:
- Call regarding a cardiac arrest registered in the national Danish Cardiac Arrest Registry
- OHCA is recognized by machine-learning model
- Call originates from 1-1-2
Exclusion Criteria:
- OHCA Emergency Medical Services - witnessed
- Call is from another authority (police or fire brigade)
- Call is a repeat call
- Call has been on hold for conference
Sites / Locations
- Emergency Medical Services Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Machine alert
Usual care
Arm Description
These cardiac suspected cardiac arrest will have had an alert generated by the machine learning model in addition to standard Emergency Medical Services response.
These suspected cardiac arrests will receive standard Emergency Medical Services response.
Outcomes
Primary Outcome Measures
Dispatcher recognition of cardiac arrest
Dispatcher recognition of out-of-hospital cardiac arrest is the primary outcome. Recognition is reported by a questionnaire filled in by a group of auditors listening to recordings of all included calls. The questionnaire is a modified CARES protocol for the calls and consists of 21 questions whereby the quality of the call is evaluated. The questionnaire is validated and has been used in other studies.
Secondary Outcome Measures
Time to recognition
Time from call-start until dispatcher recognition of cardiac arrest
Dispatcher assisted telephone CPR
Does the dispatcher ask caller to initiate CPR.
Time to T-CPR
Time from call-start until dispatcher starts guiding caller in cpr
Full Information
NCT ID
NCT04219306
First Posted
December 27, 2019
Last Updated
April 15, 2020
Sponsor
Emergency Medical Services, Capital Region, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04219306
Brief Title
Machine Learning Assisted Recognition of Out-of-Hospital Cardiac Arrest During Emergency Calls.
Official Title
Can a Machine Learning Recognise of Out-of-Hospital Cardiac Arrest During Emergency Calls and Assist Medical Dispatchers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emergency Medical Services, Capital Region, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Emergency medical Services Copenhagen has developed a machine learning model that analyzes the calls to 1-1-2 (9-1-1) in real time. The model are able to recognize calls where a cardiac arrest is suspected. The aim of the study is to investigate the effect of a computer generated alert in calls where cardiac arrest is suspected.
The study will investigate
whether a potential increase in recognitions is due to machine alerts or the increased focus of the medical dispatcher on recognizing Out-of-Hospital cardiac Arrest (OHCA) when implementing the machine
if a machine learning model based on neural networks, when alerting medical dispatchers will increase overall recognition of OHCA and increase dispatch of citizen responders.
increased use of automated external defibrillators (AED), cardiopulmonary resuscitation (CPR) or dispatch of citizen responders in cases of OHCA on machine recognised OHCA vs. medical dispatcher recognised OHCA.
Detailed Description
Chances of survival after out-of-hospital cardiac arrest decrease 10% per minute from collapse until CPR is initiated. dispatcher assisted telephone CPR will be initiated only in cases where the dispatcher recognizes the cardiac arrest.
In a previous project "Can a computer through machine learning recognise of Out-of-Hospital Cardiac Arrest during emergency calls" (supported by TrygFoundation), the investigators found, it was possible to create a Machine Learning (ML) model, which could recognise OHCA with higher precision than medical dispatchers at the Emergency Medical Dispatch Center (EMDC-Copenhagen).
In this study the model andt is effect is to be documented in the EMDC-Copenhagen. For this purpose, a computer server running the ML-model are created. This server is integrated in the network at EMDC-Copenhagen, making it possible to push alerts to the medical dispatcher, when a cardiac arrest is recognised by the model.
With aid of machine learning, the hypothesis is, that recognition of OHCA is improved, and happen both more frequent and faster than present.
An instruction for the medical dispatchers is developed, which guides the medical dispatcher in instance of an alert from the machine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest
Keywords
Machine learning, Artificial intelligence, Dispatcher assisted telephone CPR, Heart Arrest, Heart Diseases, Cardiovascular Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study has been designed as a prospective, blinded, randomized clinical trial (RCT). Each call where the machine learning model suspects a cardiac arrest is by lot (1:1) randomized to either alert on dispatchers' screen or no alert on dispatchers' screen
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
5242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Machine alert
Arm Type
Experimental
Arm Description
These cardiac suspected cardiac arrest will have had an alert generated by the machine learning model in addition to standard Emergency Medical Services response.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
These suspected cardiac arrests will receive standard Emergency Medical Services response.
Intervention Type
Other
Intervention Name(s)
Alert on dispatchers screen 'Suspect cardiac arrest'
Intervention Description
Alert on dispatchers screen 'Suspect cardiac arrest'
Primary Outcome Measure Information:
Title
Dispatcher recognition of cardiac arrest
Description
Dispatcher recognition of out-of-hospital cardiac arrest is the primary outcome. Recognition is reported by a questionnaire filled in by a group of auditors listening to recordings of all included calls. The questionnaire is a modified CARES protocol for the calls and consists of 21 questions whereby the quality of the call is evaluated. The questionnaire is validated and has been used in other studies.
Time Frame
During call to emergency Medical Services, up to 15 minutes from call start.
Secondary Outcome Measure Information:
Title
Time to recognition
Description
Time from call-start until dispatcher recognition of cardiac arrest
Time Frame
During call to emergency Medical Services, up to 15 minutes from call start.
Title
Dispatcher assisted telephone CPR
Description
Does the dispatcher ask caller to initiate CPR.
Time Frame
During call to emergency Medical Services, up to 15 minutes from call start.
Title
Time to T-CPR
Description
Time from call-start until dispatcher starts guiding caller in cpr
Time Frame
During call to emergency Medical Services, up to 15 minutes from call start.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Call regarding a cardiac arrest registered in the national Danish Cardiac Arrest Registry
OHCA is recognized by machine-learning model
Call originates from 1-1-2
Exclusion Criteria:
OHCA Emergency Medical Services - witnessed
Call is from another authority (police or fire brigade)
Call is a repeat call
Call has been on hold for conference
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Freddy Lippert, MD
Organizational Affiliation
Copenhagen Emergency Medical Services
Official's Role
Study Director
Facility Information:
Facility Name
Emergency Medical Services Copenhagen
City
Ballerup
State/Province
Danmark
ZIP/Postal Code
DK-2750
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon reasonable request by mail to primary investigator.
Citations:
PubMed Identifier
30664917
Citation
Blomberg SN, Folke F, Ersboll AK, Christensen HC, Torp-Pedersen C, Sayre MR, Counts CR, Lippert FK. Machine learning as a supportive tool to recognize cardiac arrest in emergency calls. Resuscitation. 2019 May;138:322-329. doi: 10.1016/j.resuscitation.2019.01.015. Epub 2019 Jan 18.
Results Reference
background
PubMed Identifier
33404620
Citation
Blomberg SN, Christensen HC, Lippert F, Ersboll AK, Torp-Petersen C, Sayre MR, Kudenchuk PJ, Folke F. Effect of Machine Learning on Dispatcher Recognition of Out-of-Hospital Cardiac Arrest During Calls to Emergency Medical Services: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2032320. doi: 10.1001/jamanetworkopen.2020.32320.
Results Reference
derived
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Machine Learning Assisted Recognition of Out-of-Hospital Cardiac Arrest During Emergency Calls.
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