NCT02540629

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,670

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 30, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

August 6, 2015

Results QC Date

April 17, 2019

Last Update Submit

March 16, 2020

Conditions

Keywords

Cardiopulmonary resuscitationEmergency Medicine

Outcome Measures

Primary Outcomes (1)

  • 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.

    At hospital discharge, up to 28 weeks from hospital admission

Secondary Outcomes (1)

  • Number of Participants With Good Neurological Recovery at Discharge

    At hospital discharge, up to 28 weeks from hospital admission

Study Arms (2)

Before intervention

NO 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.

After intervention

EXPERIMENTAL

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.

Procedure: Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device

Interventions

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.

After intervention

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Jeong Ho Park
Organization
Seoul National University Hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2015

First Posted

September 4, 2015

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 30, 2020

Results First Posted

March 30, 2020

Record last verified: 2020-03

Locations