CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA

Out-of-hospital Cardiac Arrest Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527694
• Other study ID #: SNUH-EM-2015-2P
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: December 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• Flexible EMS stretcher cart
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.
• mechanical CPR

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CPR Duration		During total prehospital resuscitation