CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA

Study Overview
=================
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.

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

Conditions
-----------------
Out-of-hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Device: Flexible EMS stretcher cart
* Device: mechanical CPR


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexible EMS Stretcher Cart Group<br>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. | Device: Flexible EMS stretcher cart<br>* 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.<br>Device: mechanical CPR<br> <br> |
| No Intervention: Standard Stretcher Cart Group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the total prehospital resuscitation time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPR Duration |  | During total prehospital resuscitation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergency medical services, Resuscitation