Prospective Deployment of a Cardiac Arrest Response System (EDICARS) in the Emergency Department
Primary Purpose
Cardiac Arrest
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
EDICARS
Usual care
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Arrest
Eligibility Criteria
Inclusion Criteria:
- ED patients aged 20 years at recruitment
Exclusion Criteria:
- Inability to sign informed consent;
- Diagnosis of psychiatric disorders that would limit the ability to comply with the study protocol (e.g., wearing a wristband);
- Intending to leave ED against medical advice;
- Already enrolled or planning to enroll in a research study that would conflict with full participation in the study.
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EDICARS
Usual care
Arm Description
Outcomes
Primary Outcome Measures
ED-based in-hospital cardiac arrest (IHCA) and intensive care unit (ICU) admission.
The primary outcome is a composite rate of ED-based IHCA and intensive care unit (ICU) admission.
Secondary Outcome Measures
Full Information
NCT ID
NCT05480319
First Posted
July 21, 2022
Last Updated
May 9, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05480319
Brief Title
Prospective Deployment of a Cardiac Arrest Response System (EDICARS) in the Emergency Department
Official Title
Prospective Deployment of a Cardiac Arrest Response System (EDICARS) in the Emergency Department: A Cluster Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Based on data from the American Heart Association's (AHA) Get With the Guidelines-Resuscitation (GTWG-R) registry, the incidence of adult treated in-hospital cardiac arrest (IHCA) was about 10 per 1,000 bed-days (290,000 patients per year), and 15 to 20% of adult IHCA patients survived to hospital discharge (i.e., ~80% mortality). Despite the significant morbidity and mortality caused by IHCA, ED-based IHCA is surprisingly less studied. The investigators have utilized electronic medical record (EMR)'s big data (>700,000 visits) from our hospital to investigate, for the first time, the epidemiology and outcome of IHCA in the ED in Taiwan. The investigators also have developed and validated a simple prediction tool for ED-based IHCA, the Emergency Department In-hospital Cardiac Arrest Score (EDICAS). This tool has also been externally validated using Far Eastern Memorial Hospital's ED data. In addition, the investigators also have developed and validated a vital-sign trajectory-based longitudinal model (group-based trajectory modeling [GBTM]) to predict ED-based IHCA.
Based on these studies, the investigators now propose to (1) Embed the EDICAS into our hospital information system (HIS) in real-time at ED triage to identify high-risk patients (EDICAS 6+); and (2) Distribute wearable smart wristbands to high-risk patients to augment vital signs monitoring and send alerts based on GBTM results. The detection and intervention components together form the rapid response system, the Emergency Department In-hospital Cardiac Arrest Response System (EDICARS). In this study, the investigators will enroll and randomize 10 attending physicians into the EDICARS or the usual care arm for 3 months, with each of them treating 100 patients (patients clustered within physicians). The trial will stop for 2 months as a wash-out period, and an interim analysis will be performed. The physicians will then cross over, and each of them will treat 100 patients for another 3 months. A total of 2,000 adult patients will be enrolled. The primary outcome is a composite rate of ED-based IHCA and intensive care unit (ICU) admission. The secondary outcomes include time from ED triage to ED-based cardiac arrest, ICU and hospital length of stay, early ward-based IHCA, and early ICU transfer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2010 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EDICARS
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
EDICARS
Intervention Description
The investigators propose to (1) Embed the EDICAS into our hospital information system (HIS) in real-time at ED triage to identify high-risk patients (EDICAS 6+); and (2) Distribute wearable smart wristbands to high-risk patients to augment vital signs monitoring and send alerts based on GBTM results. The detection and intervention components together form the rapid response system, the Emergency Department In-hospital Cardiac Arrest Response System (EDICARS).
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care will be assigned to this arm. No additional interventions.
Primary Outcome Measure Information:
Title
ED-based in-hospital cardiac arrest (IHCA) and intensive care unit (ICU) admission.
Description
The primary outcome is a composite rate of ED-based IHCA and intensive care unit (ICU) admission.
Time Frame
During the stay in the emergency department, a median length of 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ED patients aged 20 years at recruitment
Exclusion Criteria:
Inability to sign informed consent;
Diagnosis of psychiatric disorders that would limit the ability to comply with the study protocol (e.g., wearing a wristband);
Intending to leave ED against medical advice;
Already enrolled or planning to enroll in a research study that would conflict with full participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chu-Lin Tsai, MD
Phone
+886-2-2312-3456
Ext
67684
Email
chulintsai@ntu.edu.tw
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chu-Lin Tsai, MD
12. IPD Sharing Statement
Learn more about this trial
Prospective Deployment of a Cardiac Arrest Response System (EDICARS) in the Emergency Department
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