NCT03041350

Brief Summary

Direct medical control using video conferencing capabilities of smartphones has never been conducted in out-of-hospital cardiac arrest patients. This study was conducted to investigate its feasibility and treatment effectiveness in out-of-hospital cardiac arrest (OHCA) patients using a real-time smartphone video call.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

December 11, 2016

Last Update Submit

January 31, 2017

Conditions

Out-of-Hospital Cardiac Arrest

Keywords

Emergency Medical ServicesSmartphoneSurvival

Outcome Measures

Primary Outcomes (2)

  • survival rate

    1 year

  • favorable neurologic outcome rate

    1 year

Secondary Outcomes (1)

  • rate of prehospital return of systemic circulation(ROSC)

    through study completion, an average of 1 year

Other Outcomes (1)

  • feasibility

    through study completion, an average of 1 year

Study Arms (1)

Smartphone video-assisted ALS & Conventional CPR

EXPERIMENTAL

In study period, using this video medical control, high-quality CPR, cardiac arrest rhythm confirmation, defibrillation, proper drug administration instructions, advanced airway insertion, etc. are performed. The medical director then decides on patient transfer if the asystole and pulseless electrical activity findings are persistent even after more than 20-minutes of ALS. The conventional CPR is Basic life support only in the automatic external defibrillator (AED) mode 5-10 minutes at the scene, are not allowed to stop resuscitation at the scene unless there is a return of spontaneous circulation (ROSC) or pre-hospital cardiac arrest patient has already been transported to a hospital.

Other: Smartphone video-assisted ALS(advanced life support)

Interventions

Smartphone video-assisted ALS(advanced life support)OTHER

As an preparation for this study, personnel training in mock advanced life support (ALS) simulation including the smartphone video call methodology was conducted. The smartphones were not separately purchased or produced; commercially available smartphones already owned by the emergency medical service (EMS) personnel and medical directors were used. To facilitate the smartphone video call between the medical director and the EMS personnel and to prevent the caregivers or others nearby from hearing the conversation, Bluetooth earphone sets were used. Data were collected using the cardiopulmonary resuscitation (CPR) recording form uploaded in SNS which consisted of EMS personnel and medical directors, and the quality of CPR was evaluated

Smartphone video-assisted ALS & Conventional CPR

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all EMS-treated OHCA patients older than 18 years transported to the hospital unless otherwise diagnosed with trauma, poisoning, asphyxia, hanging, or any other non-disease-origin factors.

You may not qualify if:

  • Patients with do-not-resuscitate (DNR) orders and with obvious signs of irreversible death, including rigor mortis and corruption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency medical service system of Suwon city

Suwon, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Gi Woon Kim, M.D., Ph.D.

    Department of Emergency Medicine, Soonchunhyang University Bucheon Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 11, 2016

First Posted

February 2, 2017

Study Start

January 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 2, 2017

Record last verified: 2017-01

Locations

KR(1)