Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02010151
• Collaborator: Korean Center for Disease Control and Prevention (Other), Seoul Metropolitan Government Health and Welfare Office (Other), Seoul Metropolitan Fire and Disaster Headquater (Other), Korea Association for Safety Community (Other)
• Enrollment: 3,194
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.1
• Patients Per Site Per Month: 96.6

Study Details

Study Description

Brief Summary

The hypothesis of this study is Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation (NAD-CPR) would improve survival of out-of-hospital cardiac arrest (OHCA).

Condition or Disease	Intervention/Treatment	Phase
Out of Hospital Cardiac Arrest	Other: NAD-CPR	N/A

Detailed Description

Out-of-hospital cardiac arrest (OHCA) is a major health problem, occurring in about 1 in 1,500 adults in the developed countries each year. Although layperson CPR and defibrillation are crucial components of chain of survival, layperson CPR rate and it's quality is low and public-access defibrillation (PAD) program is not cost-effective.If trained bystanders can know the information of occurrence of OHCA and nearest place for automated external defibrillator (AED) at the same time by dispatch center, these neighborhoods could run and give high quality CPR and early defibrillation. If this protocol ,Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation(NAD-CPR), is introduced to community, it may improve survival of OHCA.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3194 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Population Based Intervention Trial of Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NAD-CPR When dispatcher detects a patient with OHCA, the dispatcher activates trained neighborhoods by informing events nearby using short message service via cellular phone. The neighborhood within geographically accessible area who could perform effective CPR and defibrillation would be alerted with event of OHCA and the nearest AED.	Other: NAD-CPR; When Dispatcher detects OHCA, short message service (SMS)about the OHCA event and information about the location of nearest AED is sent to trained laypersons within geographically accessible area.
No Intervention: Conventional dispatcher assisted CPR When dispatcher detects OHCA, they instruct the caller with CPR instructions. This is conventional dispatcher assisted CPR performed in Seoul.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Surviving at Hospital Discharge [discharge time from first admission from emergency department within 2 month]

   we compared the survival to discharge rate between before intervention period and intervention period. Survival to discharge checked at the discharge point of hospital.

Secondary Outcome Measures

1. Number of Participants With Pre-Hospital Return of Spontaneous Circulation (ROSC) [hospital arriving time from ambulance within 2 hours]

   we compared the Pre-hospital return of spontaneous circulation (ROSC) rate between before intervention period and intervention period.

2. Number of Participants With Good Neurological Recovery [discharge time from first admission from emergency department within 2 month]

   Cerebral performance category 1 or 2 is defined as good neurological recovery. we compared the good neurological recovery rate between before intervention period and intervention period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all OHCA with presumed cardiac etiology more than 15 years old

• assessed by emergency medical service (EMS) providers dispatched by dispatch center

• dispatcher detected OHCA patients

Exclusion Criteria:

• OHCA with non-cardiac etiology

• prolonged cardiac arrest with a suspected duration more than 30 minutes

• cases with rigor mortis or rivor mortis, decapitated or decomposed body

• Non detected cases by dispatcher

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul Metropolitan City	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital
• Korean Center for Disease Control and Prevention
• Seoul Metropolitan Government Health and Welfare Office
• Seoul Metropolitan Fire and Disaster Headquater
• Korea Association for Safety Community

Investigators

• Principal Investigator: Sang Do Shin, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 23, 2018

More Information

Publications

None provided.

• Responsible Party: Sang Do Shin, Associated Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02010151
• Other Study ID Numbers: SNUEMS201309
• First Posted: Dec 12, 2013
• Last Update Posted: Mar 30, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Sang Do Shin, Associated Professor, Seoul National University Hospital: Out of Hospital Cardiac Arrest; Cardiopulmonary Resuscitation; dispatch; emergency medicine
• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest

Study Results

Participant Flow

Arm/Group Title	Conventional Dispatcher Assisted CPR	NAD-CPR
Arm/Group Description	patients enrolled in period that conventional dispatcher assisted CPR was provided to patient (January 2013 to April 2015). baseline EMS assessed OHCA: 2,418 Adult presumed cardiac etiology Resuscitation attempted Not witnessed by EMS provider Eligible for analysis Final population : 1498	patients enrolled in period that NAD-CPR was provided to patient (May 2015 to December 2017) baseline EMS assessed OHCA: 2,611 Adult presumed cardiac etiology Resuscitation attempted Not witnessed by EMS provider Eligible for analysis Final population : 1,696 (TM sent: 598)
Period Title: Overall Study
STARTED	1498	1696
COMPLETED	1498	1696
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Conventional Dispatcher CPR	NAD-CPR	Total
Arm/Group Description	patients enrolled in period that conventional dispatcher CPR was provided to the patients.	patients enrolled in period that NAD-CPR was provided to the patients.	Total of all reporting groups
Overall Participants	1498	1696	3194
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	71	72	72
Sex: Female, Male (Count of Participants)
Female	532 35.5%	577 34%	1109 34.7%
Male	966 64.5%	1119 66%	2085 65.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
South Korea	1498 100%	1696 100%	3194 100%
TM sent (Count of Participants)
Count of Participants [Participants]	0 0%	598 35.3%	598 18.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Surviving at Hospital Discharge
Description	we compared the survival to discharge rate between before intervention period and intervention period. Survival to discharge checked at the discharge point of hospital.
Time Frame	discharge time from first admission from emergency department within 2 month

Outcome Measure Data

Analysis Population Description

Study population excluding exclusion criteria

Arm/Group Title	Conventional Dispatcher CPR	NAD-CPR
Arm/Group Description	patients enrolled in period that conventional dispatcher CPR was provided to the patients.	patients enrolled in period that NAD-CPR was provided to the patients.
Measure Participants	1498	1696
Count of Participants [Participants]	135 9%	216 12.7%

2. Secondary Outcome

Title	Number of Participants With Pre-Hospital Return of Spontaneous Circulation (ROSC)
Description	we compared the Pre-hospital return of spontaneous circulation (ROSC) rate between before intervention period and intervention period.
Time Frame	hospital arriving time from ambulance within 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Dispatcher CPR	NAD-CPR
Arm/Group Description	patients enrolled in period that conventional dispatcher CPR was provided to the patients.	patients enrolled in period that NAD-CPR was provided to the patients.
Measure Participants	1498	1696
Count of Participants [Participants]	107 7.1%	223 13.1%

3. Secondary Outcome

Title	Number of Participants With Good Neurological Recovery
Description	Cerebral performance category 1 or 2 is defined as good neurological recovery. we compared the good neurological recovery rate between before intervention period and intervention period.
Time Frame	discharge time from first admission from emergency department within 2 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Dispatcher CPR	NAD-CPR
Arm/Group Description	patients enrolled in period that conventional dispatcher CPR was provided to the patients.	patients enrolled in period that NAD-CPR was provided to the patients.
Measure Participants	1498	1696
Count of Participants [Participants]	68 4.5%	140 8.3%

Adverse Events

Time Frame	from hospital arrival (from ambulance) to the hospital or ED discharge within 2 month (All patients have different time frame because all patients have different admission period)
Arm/Group Title	Conventional Dispatcher CPR		NAD-CPR
Arm/Group Description	patients enrolled in period that conventional dispatcher CPR was provided to the patients.		patients enrolled in period that NAD-CPR was provided to the patients.
All Cause Mortality
	Conventional Dispatcher CPR		NAD-CPR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1363/1498 (91%)		1480/1696 (87.3%)
Serious Adverse Events
	Conventional Dispatcher CPR		NAD-CPR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1363/1498 (91%)		1480/1696 (87.3%)
Cardiac disorders
death	1363/1498 (91%)	1363	1480/1696 (87.3%)	1480
Other (Not Including Serious) Adverse Events
	Conventional Dispatcher CPR		NAD-CPR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1498 (0%)		0/1696 (0%)

Limitations/Caveats

It's not randomized trial, it's before-after study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.