Evaluation of Effectiveness for Connected Network for EMS Comprehensive Technical-support Using Artificial Intelligence (CONNECT-AI) System by Community Intervention

July 5, 2023 updated by: Yonsei University

Evaluation of Effectiveness for Connected Network for EMS Comprehensive Technical-support Using Artificial Intelligence (CONNECT-AI) System by Community Intervention: A Prospective Crossover Interventional Study

This study aims to verify the effectiveness of the connected network for EMS comprehensive technical-support using artificial intelligence (CONNECT-AI) system through demonstration in the local community. The study was designed as a prospective non-random cross-intervention study design in two preselected communities. The subjects of the study are patients transferred to the local emergency department(ED) through an ambulance of a fire department in the selected community. If the storage and transmission of information collected by an ambulance fails or the information of the transferred patient cannot be verified in the transferred ED, it is excluded from the study. In this study, the developed CONNECT-AI system was installed in all emergency vehicles and EDs in two regional cohorts, and the effectiveness was measured by operating an intersection for the same period. The primary outcome is the transfer time spent in the pre-hospital stage, and the secondary outcome is whether the optimal transfer hospital is selected.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15392

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients transferred to the local emergency department(ED) through an ambulance of a fire department in the selected community.

Exclusion Criteria:

  • If the storage and transmission of information collected by an ambulance fails or the information of the transferred patient cannot be verified in the transferred ED

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Case
Emergency patient transferred by CONNECT AI system

A. During the Intervention period, paramedics wear equipment for multi-faceted data acquisition and press the start button of the system.

B. During the Intervention period, inside the ambulance, a application that implements a function that automatically evaluates the patient's severity, displays a list of optimal transfer hospitals based on this, and shares real-time information of the hospitals, is installed so that paramedics can refer to the work.

C. ED's medical staff will receive through ER-kiosk pre-hospital patient information collected and analyzed through the CONNECT AI system before arrival.

No Intervention: Control
Emergency patient transferred by conventional EMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
transfer time spent in the pre-hospital stage
Time Frame: up to 1 month
Time taken from the time the paramedic arrives at the scene to the transfer hospital
up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whether to select the optimal transfer hospital
Time Frame: up to 1 month
In the case of transfer to another hospital or death without resolving the emergency situation at the initial ED
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hyuk-Jae Chang, Division of Cardiology, Yonsei university college of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2021-0217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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