Out-of-Hospital Cardiac Arrest
Conditions
Keywords
Cardiopulmonary resuscitation, Emergency Medicine
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.
Interventions
PROCEDUREBundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Survival to Hospital Discharge | At hospital discharge, up to 28 weeks from hospital admission | Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Good Neurological Recovery at Discharge | At hospital discharge, up to 28 weeks from hospital admission | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional EMS CPR (2013-2014, 2 Years) Conventional EMS CPR 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. | 6,201 |
| Bundled EMS CPR (2015-2016, 2 Years) The main study phase will begin in January, 2015 through December, 2016, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable.
Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device: 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. | 6,469 |
| Total | 12,670 |
Baseline characteristics
| Characteristic | Conventional EMS CPR (2013-2014, 2 Years) | Total | Bundled EMS CPR (2015-2016, 2 Years) |
|---|---|---|---|
| Age, Continuous | 72 years | 72 years | 73 years |
| Bystander CPR Bystander CPR with dispatcher assistace | 2357 Participants | 5223 Participants | 2866 Participants |
| Bystander CPR Bystander CPR without dispatcher assistace | 1105 Participants | 2182 Participants | 1077 Participants |
| Bystander CPR No bystander CPR | 2739 Participants | 5265 Participants | 2526 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6201 Participants | 12670 Participants | 6469 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Feedback CPR | 1628 Participants | 5606 Participants | 3978 Participants |
| Initial shockable rhythm | 696 Participants | 1415 Participants | 719 Participants |
| Multi-tier response Multi-tier with ambulance | 0 Participants | 2080 Participants | 2080 Participants |
| Multi-tier response Multi-tier with fireengine | 0 Participants | 342 Participants | 342 Participants |
| Multi-tier response Single tier | 6201 Participants | 10248 Participants | 4047 Participants |
| Prehospital ROSC | 471 Participants | 1172 Participants | 701 Participants |
| Public place | 1180 Participants | 2441 Participants | 1261 Participants |
| Region of Enrollment South Korea | 6201 participants | 12670 participants | 6469 participants |
| Sex: Female, Male Female | 2227 Participants | 4571 Participants | 2344 Participants |
| Sex: Female, Male Male | 3974 Participants | 8099 Participants | 4125 Participants |
| Witnessed | 3119 Participants | 6472 Participants | 3353 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5,607 / 6,201 | 5,762 / 6,469 |
| other Total, other adverse events | 0 / 6,201 | 0 / 6,469 |
| serious Total, serious adverse events | 0 / 6,201 | 0 / 6,469 |
Outcome results
Primary
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.
Time frame: At hospital discharge, up to 28 weeks from hospital admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional EMS CPR | Number of Participants With Survival to Hospital Discharge | 594 Participants |
| Bundled EMS CPR | Number of Participants With Survival to Hospital Discharge | 707 Participants |
p-value: 0.01Chi-squared
Secondary
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.
Time frame: At hospital discharge, up to 28 weeks from hospital admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional EMS CPR | Number of Participants With Good Neurological Recovery at Discharge | 334 Participants |
| Bundled EMS CPR | Number of Participants With Good Neurological Recovery at Discharge | 441 Participants |