Out-of-hospital Cardiac Arrest
Conditions
Keywords
Emergency medical services, Resuscitation
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.
Interventions
DEVICEFlexible 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.
DEVICEmechanical CPR
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| CPR Duration | During total prehospital resuscitation |
Countries
South Korea
Participant flow
Recruitment details
Adult OHCAs transported by five ambulances in a metropolitan area with a population of 3.5 million (many of whom lived in high-rise buildings) from September to October (before-phase) and November to December (afterphase) in 2015 were collected.
Participants by arm
| Arm | Count |
|---|---|
| Standard Stretcher Cart Group Standard strecher for manual compression on supine position | 21 |
| Flexible Stretcher Cart Group We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study. | 10 |
| Total | 31 |
Baseline characteristics
| Characteristic | Flexible Stretcher Cart Group | Total | Standard Stretcher Cart Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 17 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 14 Participants | 10 Participants |
| Age, Continuous | 66 years | 66 years | 66 years |
| Region of Enrollment South Korea | 10 Participants | 31 Participants | 21 Participants |
| Sex: Female, Male Female | 2 Participants | 10 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 21 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 20 |
| serious Total, serious adverse events | 0 / 29 | 0 / 20 |
Outcome results
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.
Time frame: During the total prehospital resuscitation time
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Stretcher Cart Group | Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups | 80.1 Percentage of chest compression fraction |
| Flexible Stretcher Cart Group | Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups | 85.2 Percentage of chest compression fraction |
Secondary
CPR Duration
Time frame: During total prehospital resuscitation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Stretcher Cart Group | CPR Duration | 909 seconds |
| Flexible Stretcher Cart Group | CPR Duration | 1131 seconds |