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

Primary Purpose

Out-of-Hospital Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Smartphone video-assisted ALS(advanced life support)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Out-of-Hospital Cardiac Arrest focused on measuring Emergency Medical Services, Smartphone, Survival

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emergency medical service system of Suwon city

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Smartphone video-assisted ALS & Conventional CPR

Arm Description

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.

Outcomes

Primary Outcome Measures

survival rate
favorable neurologic outcome rate

Secondary Outcome Measures

rate of prehospital return of systemic circulation(ROSC)

Full Information

First Posted
December 11, 2016
Last Updated
January 31, 2017
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Public Safety and Security, Ajou University School of Medicine, Saint Vincent's Hospital, Korea, Soonchunhyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03041350
Brief Title
Smartphone Video-assisted Advanced Life Support of Patients With Out-of-hospital Cardiac Arrest by EMS Under Physician Direction
Acronym
SWALS
Official Title
Smartphone Video-assisted Advanced Life Support of Patients With Out-of-hospital Cardiac Arrest by EMS Under Physician Direction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Public Safety and Security, Ajou University School of Medicine, Saint Vincent's Hospital, Korea, Soonchunhyang University Hospital

4. Oversight

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-Hospital Cardiac Arrest
Keywords
Emergency Medical Services, Smartphone, Survival

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone video-assisted ALS & Conventional CPR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Smartphone video-assisted ALS(advanced life support)
Intervention Description
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
Primary Outcome Measure Information:
Title
survival rate
Time Frame
1 year
Title
favorable neurologic outcome rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
rate of prehospital return of systemic circulation(ROSC)
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
feasibility
Description
Confidence scores of 10 items for determining CPR performances which is measured on a 10 point likert scale by physicians
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gi Woon Kim, M.D., Ph.D.
Organizational Affiliation
Department of Emergency Medicine, Soonchunhyang University Bucheon Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency medical service system of Suwon city
City
Suwon city
State/Province
Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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