CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA

Not Applicable

Completed

• Conditions: Out-of-hospital Cardiac Arrest
• Interventions: Device: Flexible EMS stretcher cart; Device: mechanical CPR

• Registration Number: NCT02527694
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Study Start: 2015-09
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Results First Submitted: 2018-01-15
• Results First Submitted QC: 2018-03-16
• Results First Posted: 2018-11-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-31
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexible EMS Stretcher Cart Group	Flexible EMS stretcher cart	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.
Flexible EMS Stretcher Cart Group	mechanical CPR	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.

Primary Outcome Measures

Name	Time	Method
Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups	During the total prehospital resuscitation time	Chest compression fraction was calculated as proportion of CPR time spent providing compressions.

Secondary Outcome Measures

Name	Time	Method
CPR Duration	During total prehospital resuscitation

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of