NCT04219306

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

  1. 1.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
  2. 2.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.
  3. 3.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

December 27, 2019

Last Update Submit

April 15, 2020

Conditions

Keywords

Machine learningArtificial intelligenceDispatcher assisted telephone CPRHeart ArrestHeart DiseasesCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    During call to emergency Medical Services, up to 15 minutes from call start.

Secondary Outcomes (3)

  • Time to recognition

    During call to emergency Medical Services, up to 15 minutes from call start.

  • Dispatcher assisted telephone CPR

    During call to emergency Medical Services, up to 15 minutes from call start.

  • Time to T-CPR

    During call to emergency Medical Services, up to 15 minutes from call start.

Study Arms (2)

Machine alert

EXPERIMENTAL

These cardiac suspected cardiac arrest will have had an alert generated by the machine learning model in addition to standard Emergency Medical Services response.

Other: Alert on dispatchers screen 'Suspect cardiac arrest'

Usual care

NO INTERVENTION

These suspected cardiac arrests will receive standard Emergency Medical Services response.

Interventions

Alert on dispatchers screen 'Suspect cardiac arrest'

Machine alert

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Medical Services Copenhagen

Ballerup Municipality, Danmark, DK-2750, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 30664917BACKGROUND
  • 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.

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Freddy Lippert, MD

    Copenhagen Emergency Medical Services

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD-fellow

Study Record Dates

First Submitted

December 27, 2019

First Posted

January 7, 2020

Study Start

September 1, 2018

Primary Completion

April 1, 2020

Study Completion

April 2, 2020

Last Updated

April 16, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Data will be available upon reasonable request by mail to primary investigator.

Locations