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Implementation of Gold Standard EMS CPR Programs for 2% Improvement in Survival Rates of Out-of-Hospital Cardiac Arrest in a Metropolitan City (2% Project)

Primary Purpose

Out-of-Hospital Cardiac Arrest

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-of-Hospital Cardiac Arrest focused on measuring Cardiopulmonary resuscitation, Emergency Medicine

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • EMS-assessed OHCA
  • Cardiac etiology
  • Above 15 years of age

Exclusion Criteria:

  • Patients who do not receive EMS resuscitation
  • Patients with signs of evident death (decapitation, evident livor mortis or rigor mortis)
  • Do-Not-Resuscitate cases
  • Pregnant patients
  • Patients whom the mechanical devices cannot be applied to

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Before intervention

After intervention

Arm Description

The before intervention group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions.

The main study phase was planned to begin in January, 2016 through December, 2017, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable. However, because we could not continue our project in 2017, we changed after period. We included implementation period (2015) in after period. Therefore, final after period begins in January 2015 to December 2016.

Outcomes

Primary Outcome Measures

Number of Participants With Survival to Hospital Discharge
Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge will be recorded.

Secondary Outcome Measures

Number of Participants With Good Neurological Recovery at Discharge
Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge and has cerebral performance category 1 or 2 will be recorded.

Full Information

First Posted
August 6, 2015
Last Updated
March 16, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02540629
Brief Title
Implementation of Gold Standard EMS CPR Programs for 2% Improvement in Survival Rates of Out-of-Hospital Cardiac Arrest in a Metropolitan City
Acronym
2% Project
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Human resource change in Research investigators and Seoul Fire Department
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to improve the survival rate of out-of-hospital cardiac arrest patients by 2% through a bundle of three intervention measures including: 1) dispatcher-assisted CPR, 2) multi-tiered response team CPR, and 3) feedback CPR.
Detailed Description
The project aims to implement gold standard emergency medical services (EMS) cardiopulmonary resuscitation (CPR) programs, which will result in increased bystander CPR, reduced EMS response time, and high quality CPR during prehospital resuscitation through a bundled approach including 1) dispatcher-assisted CPR (DA-CPR), 2) multi-tiered response team CPR, and 3) feedback CPR. The DA-CPR program aims to contribute to improved bystander CPR rate and reduced EMS response time interval through rigorous monitoring of cardiac arrest detection at primary call receiving stage as well as increased number of dispatcher-assisted CPR instruction initiation in the target time of 90 seconds. The Team CPR protocol will render synergetic efforts among participating EMS personnel from both basic life support (BLS) and advanced life support (ALS) units within the new tiered dispatch system and subsequently deliver uninterrupted CPR to out-of-hospital cardiac arrest (OHCA) patients before hospital arrival. The feedback CPR monitoring and quality assurance program will contribute to high quality CPR delivered to the patients on the scene as well as during transport.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-Hospital Cardiac Arrest
Keywords
Cardiopulmonary resuscitation, Emergency Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12670 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Before intervention
Arm Type
No Intervention
Arm Description
The before intervention group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions.
Arm Title
After intervention
Arm Type
Experimental
Arm Description
The main study phase was planned to begin in January, 2016 through December, 2017, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable. However, because we could not continue our project in 2017, we changed after period. We included implementation period (2015) in after period. Therefore, final after period begins in January 2015 to December 2016.
Intervention Type
Procedure
Intervention Name(s)
Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device
Intervention Description
Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR.
Primary Outcome Measure Information:
Title
Number of Participants With Survival to Hospital Discharge
Description
Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge will be recorded.
Time Frame
At hospital discharge, up to 28 weeks from hospital admission
Secondary Outcome Measure Information:
Title
Number of Participants With Good Neurological Recovery at Discharge
Description
Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge and has cerebral performance category 1 or 2 will be recorded.
Time Frame
At hospital discharge, up to 28 weeks from hospital admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: EMS-assessed OHCA Cardiac etiology Above 15 years of age Exclusion Criteria: Patients who do not receive EMS resuscitation Patients with signs of evident death (decapitation, evident livor mortis or rigor mortis) Do-Not-Resuscitate cases Pregnant patients Patients whom the mechanical devices cannot be applied to
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Implementation of Gold Standard EMS CPR Programs for 2% Improvement in Survival Rates of Out-of-Hospital Cardiac Arrest in a Metropolitan City

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