- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02540629
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)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Before intervention
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.
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Experimental: After intervention
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants With Survival to Hospital Discharge
Time Frame: At hospital discharge, up to 28 weeks from hospital admission
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Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge will be recorded.
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At hospital discharge, up to 28 weeks from hospital admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants With Good Neurological Recovery at Discharge
Time Frame: At hospital discharge, up to 28 weeks from hospital admission
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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.
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At hospital discharge, up to 28 weeks from hospital admission
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNUH-EM-2015-3
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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