Clinical trial NCT02527694: CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA
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
Overall status: COMPLETED
Phase: NA
Conditions: Out-of-hospital Cardiac Arrest
Keywords: Emergency medical services
Resuscitation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups
timeFrame: During the total prehospital resuscitation time
Secondary outcomes:
measure: CPR Duration
timeFrame: During total prehospital resuscitation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang Do Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: