Smartphone Video-assisted Advanced Life Support of Patients With Out-of-hospital Cardiac Arrest by EMS Under Physician Direction (SWALS)

January 31, 2017 updated by: Yu Jin Kim, MD, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

If cardiac arrest is suspected, the EMS personnel contacted the medical director before arriving at the scene. Upon the arrival at the scene of the two activated paramedic teams, they rapidly switch to ALS under teamwork-based BLS and video medical control. 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. After initiating the transfer, the medical director contacts the hospital where the patient is to be transferred to after completing the video medical control. The medical director provides an explanation of the treatment to the caregiver via video. After returning to the fire station, the EMS personnel who had completed the patient's transfer the enters the information by hand on the separate form, takes a picture of the document, and uploads it to SNS within 24 hours. Through this information shared via SNS, the research staff the provides a direct feedback to the EMS personnel, and further discussion performed within the SNS. All the incident cases of OHCA during the before and during interventional periods were registered using an EMS run sheet for basic ambulance operation information, the EMS cardiac arrest registry for the Utstein factors, and the OHCA registry for the hospital care and survival outcomes. The EMS run sheet and EMS cardiac arrest registry were collected by the EMS providers. The medical records for hospital care and outcomes were abstracted by the trained reviewer for this study

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon city, Gyeonggi-do, Korea, Republic of
        • Emergency medical service system of Suwon city

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Smartphone video-assisted ALS & Conventional CPR

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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival rate
Time Frame: 1 year
1 year
favorable neurologic outcome rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
rate of prehospital return of systemic circulation(ROSC)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility
Time Frame: through study completion, an average of 1 year
Confidence scores of 10 items for determining CPR performances which is measured on a 10 point likert scale by physicians
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ajou University School of Medicine
Soonchunhyang University Hospital
Saint Vincent's Hospital, Korea
Ministry of Public Safety and Security

Investigators

  • Principal Investigator: Gi Woon Kim, M.D., Ph.D., Department of Emergency Medicine, Soonchunhyang University Bucheon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

December 11, 2016

First Submitted That Met QC Criteria

January 31, 2017

First Posted (ESTIMATE)

February 2, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWALS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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