NCT02527694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 5, 2018

Completed
Last Updated

January 15, 2019

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

August 6, 2015

Results QC Date

January 15, 2018

Last Update Submit

December 31, 2018

Conditions

Out-of-hospital Cardiac Arrest

Keywords

Emergency medical servicesResuscitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • CPR Duration

    During total prehospital resuscitation

Study Arms (2)

Flexible EMS Stretcher Cart Group

EXPERIMENTAL

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 cartDevice: mechanical CPR

Standard Stretcher Cart Group

NO INTERVENTION

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.

Interventions

Flexible EMS stretcher cartDEVICE

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.

Flexible EMS Stretcher Cart Group
mechanical CPRDEVICE
Flexible EMS Stretcher Cart Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
So Yeon Kong
Organization
Seoul National University Hospital
soyeon.kong@gmail.com
82220724412

Study Officials

  • Sang Do Shin, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 19, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

January 15, 2019

Results First Posted

November 5, 2018

Record last verified: 2018-12

Locations

KR(1)