Evaluation of Effectiveness for Connected Network for EMS Comprehensive Technical-support Using Artificial Intelligence (CONNECT-AI) System by Community Intervention
Primary Purpose
Emergency Patient Transported by Ambulance
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CONNECT AI system group
Sponsored by

About this trial
This is an interventional health services research trial for Emergency Patient Transported by Ambulance
Eligibility Criteria
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
Sites / Locations
- Yonsei University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Case
Control
Arm Description
Emergency patient transferred by CONNECT AI system
Emergency patient transferred by conventional EMS
Outcomes
Primary Outcome Measures
transfer time spent in the pre-hospital stage
Time taken from the time the paramedic arrives at the scene to the transfer hospital
Secondary Outcome Measures
Whether to select the optimal transfer hospital
In the case of transfer to another hospital or death without resolving the emergency situation at the initial ED
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04829279
Brief Title
Evaluation of Effectiveness for Connected Network for EMS Comprehensive Technical-support Using Artificial Intelligence (CONNECT-AI) System by Community Intervention
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Patient Transported by Ambulance
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15392 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case
Arm Type
Experimental
Arm Description
Emergency patient transferred by CONNECT AI system
Arm Title
Control
Arm Type
No Intervention
Arm Description
Emergency patient transferred by conventional EMS
Intervention Type
Other
Intervention Name(s)
CONNECT AI system group
Intervention Description
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.
Primary Outcome Measure Information:
Title
transfer time spent in the pre-hospital stage
Description
Time taken from the time the paramedic arrives at the scene to the transfer hospital
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
Whether to select the optimal transfer hospital
Description
In the case of transfer to another hospital or death without resolving the emergency situation at the initial ED
Time Frame
up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyuk-Jae Chang
Organizational Affiliation
Division of Cardiology, Yonsei university college of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Effectiveness for Connected Network for EMS Comprehensive Technical-support Using Artificial Intelligence (CONNECT-AI) System by Community Intervention
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