## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 4-2021-0217
#### Organization
**Class:** OTHER
**Full Name:** Yonsei University
### Status Module
#### Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-07

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2021-05-01

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2021-04-02
**Type:** ACTUAL
**Study First Submit Date:** 2021-03-29
**Study First Submit QC Date:** 2021-03-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yonsei University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Emergency Patient Transported by Ambulance

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 15392

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Emergency patient transferred by CONNECT AI system

**Intervention Names:**

- Other: CONNECT AI system group

**Label:** Case

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Emergency patient transferred by conventional EMS

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Case

**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.

**Name:** CONNECT AI system group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Time taken from the time the paramedic arrives at the scene to the transfer hospital

**Measure:** transfer time spent in the pre-hospital stage

**Time Frame:** up to 1 month

#### Secondary Outcomes

**Description:** In the case of transfer to another hospital or death without resolving the emergency situation at the initial ED

**Measure:** Whether to select the optimal transfer hospital

**Time Frame:** up to 1 month

### Eligibility Module

**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

**Maximum Age:** 100 Years

**Minimum Age:** 0 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Yonsei University

#### Overall Officials

**Official 1:**

**Affiliation:** Division of Cardiology, Yonsei university college of medicine

**Name:** Hyuk-Jae Chang

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004630

- Term: Emergencies

### Misc Info Module

- Version Holder: 2024-05-24
