Trial Outcomes & Findings for Implementation of Gold Standard EMS CPR Programs for 2% Improvement in Survival Rates of Out-of-Hospital Cardiac Arrest in a Metropolitan City (NCT NCT02540629)
NCT ID: NCT02540629
Last Updated: 2020-03-30
Results Overview
Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge will be recorded.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12670 participants
Primary outcome timeframe
At hospital discharge, up to 28 weeks from hospital admission
Results posted on
2020-03-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6201
|
6469
|
|
Overall Study
COMPLETED
|
6201
|
6469
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementation of Gold Standard EMS CPR Programs for 2% Improvement in Survival Rates of Out-of-Hospital Cardiac Arrest in a Metropolitan City
Baseline characteristics by cohort
| Measure |
Conventional EMS CPR (2013-2014, 2 Years)
n=6201 Participants
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.
|
Bundled EMS CPR (2015-2016, 2 Years)
n=6469 Participants
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.
|
Total
n=12670 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
73 years
n=7 Participants
|
72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2227 Participants
n=5 Participants
|
2344 Participants
n=7 Participants
|
4571 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3974 Participants
n=5 Participants
|
4125 Participants
n=7 Participants
|
8099 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6201 Participants
n=5 Participants
|
6469 Participants
n=7 Participants
|
12670 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
6201 participants
n=5 Participants
|
6469 participants
n=7 Participants
|
12670 participants
n=5 Participants
|
|
Public place
|
1180 Participants
n=5 Participants
|
1261 Participants
n=7 Participants
|
2441 Participants
n=5 Participants
|
|
Witnessed
|
3119 Participants
n=5 Participants
|
3353 Participants
n=7 Participants
|
6472 Participants
n=5 Participants
|
|
Bystander CPR
No bystander CPR
|
2739 Participants
n=5 Participants
|
2526 Participants
n=7 Participants
|
5265 Participants
n=5 Participants
|
|
Bystander CPR
Bystander CPR with dispatcher assistace
|
2357 Participants
n=5 Participants
|
2866 Participants
n=7 Participants
|
5223 Participants
n=5 Participants
|
|
Bystander CPR
Bystander CPR without dispatcher assistace
|
1105 Participants
n=5 Participants
|
1077 Participants
n=7 Participants
|
2182 Participants
n=5 Participants
|
|
Initial shockable rhythm
|
696 Participants
n=5 Participants
|
719 Participants
n=7 Participants
|
1415 Participants
n=5 Participants
|
|
Multi-tier response
Single tier
|
6201 Participants
n=5 Participants
|
4047 Participants
n=7 Participants
|
10248 Participants
n=5 Participants
|
|
Multi-tier response
Multi-tier with ambulance
|
0 Participants
n=5 Participants
|
2080 Participants
n=7 Participants
|
2080 Participants
n=5 Participants
|
|
Multi-tier response
Multi-tier with fireengine
|
0 Participants
n=5 Participants
|
342 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
Feedback CPR
|
1628 Participants
n=5 Participants
|
3978 Participants
n=7 Participants
|
5606 Participants
n=5 Participants
|
|
Prehospital ROSC
|
471 Participants
n=5 Participants
|
701 Participants
n=7 Participants
|
1172 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At hospital discharge, up to 28 weeks from hospital admissionNumber of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge will be recorded.
Outcome measures
| Measure |
Conventional EMS CPR
n=6201 Participants
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.
|
Bundled EMS CPR
n=6469 Participants
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.
|
|---|---|---|
|
Number of Participants With Survival to Hospital Discharge
|
594 Participants
|
707 Participants
|
SECONDARY outcome
Timeframe: At hospital discharge, up to 28 weeks from hospital admissionNumber 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.
Outcome measures
| Measure |
Conventional EMS CPR
n=6201 Participants
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.
|
Bundled EMS CPR
n=6469 Participants
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.
|
|---|---|---|
|
Number of Participants With Good Neurological Recovery at Discharge
|
334 Participants
|
441 Participants
|
Adverse Events
Conventional EMS CPR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5607 deaths
Bundled EMS CPR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5762 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place