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CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA (ASIA-CPR)

Primary Purpose

Out-of-hospital Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Flexible EMS stretcher cart
mechanical CPR
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-of-hospital Cardiac Arrest focused on measuring Emergency medical services, Resuscitation

Eligibility Criteria

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

Inclusion Criteria:

  • All EMS-assessed OHCA in (3-4) selected districts in Seoul
  • 18 years or older of age

Exclusion Criteria:

  • Do-Not-Resuscitation cases or OHCA occurring in result of terminal diseases
  • Signs of evident death (decapitation, evident livor mortis or rigor mortis)
  • Pregnant
  • Physique too large for mechanical CPR device application
  • Chest deformation or injury
  • EMS CPR quality not assessed by the defibrillator
  • Return of spontaneous circulation (ROSC) before scene departure
  • Cardiac arrest cases during transport

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Flexible EMS Stretcher Cart Group

Standard Stretcher Cart Group

Arm Description

Patients in this group will be transported on the new flexible EMS stretcher cart and receive mechanical CPR during transport to the hospital. The intervention will be given during elevator transport (if applicable) as well as in the moving ambulance.

Patients in this group will be transported on the standard stretcher cart and receive manual CPR during transport to the hospital. The resuscitation protocol will follow the current standard protocol used by the EMS providers.

Outcomes

Primary Outcome Measures

Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups
Chest compression fraction was calculated as proportion of CPR time spent providing compressions.

Secondary Outcome Measures

CPR Duration

Full Information

First Posted
August 6, 2015
Last Updated
December 31, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02527694
Brief Title
CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA
Acronym
ASIA-CPR
Official Title
Comparison of Quality of Cardiopulmonary Resuscitation Between Flexible Stretcher and Standard Stretcher in Out-of-Hospital Cardiac Arrest: Ambulance Stretcher Innovation of Asian CPR (ASIA-CPR) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to compare the quality of emergency medical services cardiopulmonary resuscitation between flexible stretcher and standard stretcher during ambulance transport to hospital among out-of-hospital cardiac arrest patients.
Detailed Description
Background: Cardiopulmonary resuscitation (CPR) during ambulance transport in Asia has been known to be ineffective for quality and unsafe for emergency medical services(EMS)providers. Small elevators in high rise buildings are the most serious barriers to provide high quality CPR due to too long stretcher cart to enter in the elevators. We developed flexible stretcher cart to be safely used in small elevator through reducing the length of the stretcher. This study aims to compare the quality of EMS CPR between flexible stretcher and standard stretcher during transport to hospital. Method: This is a before and after-trial in a metropolis EMS. Study targets are adult out-of-hospital cardiac arrest (OHCA), excluding evident death cases, pregnancy, DNR cases, and too big or too small body size for stretcher cart or mechanical CPR devices. In the before period, the standard stretcher will be used for manual CPR using standard CPR protocol. In the after period, the flexible stretcher will be used with mechanical CPR devices after 3 cycles of standard manual CPR. Individual and Utstein risk factors will be collected. Main outcomes are no-flow fraction (NFF) measured by defibrillators (X-series) and safety will be measured on mechanical error, transportation error, patient injury and EMS provider injury. Sample size were 24 cases for before (12 cases) and after (12 cases) trial from 80% power and 0.05 of alpha error for expecting 20% quality difference (30% NFF inflexible stretcher and 50% NFF in standard stretcher) Expected impact: The study will be expected to find the benefit of flexible stretcher cart during CPR in small elevators. This findings will contribute to revise the Asian EMS protocol for improving quality of CPR.

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, Resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flexible EMS Stretcher Cart Group
Arm Type
Experimental
Arm Description
Patients in this group will be transported on the new flexible EMS stretcher cart and receive mechanical CPR during transport to the hospital. The intervention will be given during elevator transport (if applicable) as well as in the moving ambulance.
Arm Title
Standard Stretcher Cart Group
Arm Type
No Intervention
Arm Description
Patients in this group will be transported on the standard stretcher cart and receive manual CPR during transport to the hospital. The resuscitation protocol will follow the current standard protocol used by the EMS providers.
Intervention Type
Device
Intervention Name(s)
Flexible EMS stretcher cart
Intervention Description
The flexible EMS stretcher cart is an innovative EMS stretcher cart built to be flexible to fit in smaller spaces such as elevators. The flexible stretcher bends at the hip joint as well as at the knee joint, so that the patient can be put in head-up position at 30 degrees elevation with elevated legs.
Intervention Type
Device
Intervention Name(s)
mechanical CPR
Primary Outcome Measure Information:
Title
Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups
Description
Chest compression fraction was calculated as proportion of CPR time spent providing compressions.
Time Frame
During the total prehospital resuscitation time
Secondary Outcome Measure Information:
Title
CPR Duration
Time Frame
During total prehospital resuscitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All EMS-assessed OHCA in (3-4) selected districts in Seoul 18 years or older of age Exclusion Criteria: Do-Not-Resuscitation cases or OHCA occurring in result of terminal diseases Signs of evident death (decapitation, evident livor mortis or rigor mortis) Pregnant Physique too large for mechanical CPR device application Chest deformation or injury EMS CPR quality not assessed by the defibrillator Return of spontaneous circulation (ROSC) before scene departure Cardiac arrest cases during transport
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Do Shin, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA

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