NCT04135547

Brief Summary

Overall survival of patients after out-of-hospital cardiac arrest (\*OHCA\*) is less than 10% worldwide and in Taiwan. Interventions provided by the emergency medical system (\*EMS\*) before arrival at the hospital are of paramount importance to patient outcomes after OHCA. Among those interventions, the pros-and-cons of different vascular accesses, including intraosseous (\*IO\*) access or intravenous (\*IV\*) access, remained the issue of most under debate. The objective of this study is to determine the comparative effectiveness of IO access vs IV access in patients with OHCA by a randomized controlled trial (\*RCT\*) in Taipei EMS. To name in short, the investigators called it a "\*VICTOR\* trial" standing for "Venous Injection Compared To intraOsseous injection during Resuscitation of patients with out-of-hospital cardiac arrest".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,732

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

July 6, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

October 16, 2019

Last Update Submit

October 19, 2023

Conditions

Emergency Medical ServiceOut-of-Hospital Cardiac ArrestVascular AccessIntraosseous AccessIntravenous Access

Outcome Measures

Primary Outcomes (1)

  • the rate of survival to hospital discharge

    OHCA patients with survival to hospital discharge

    up to 1 month after the OHCA event

Secondary Outcomes (3)

  • the time and rate of return of spontaneous circulation (*ROSC*)

    up to 1 week after the OHCA event

  • survival to admission

    up to 1 week after the OHCA event

  • favorable neurologic survival staus

    up to 1 month after the OHCA event

Other Outcomes (1)

  • subgroups analysis

    through study completion, an average of half a year

Study Arms (2)

intra-osseous access, IO at the humeral site

EXPERIMENTAL

the OHCA patients receiving IO at the humeral site by paramedics in the field

Device: intra-osseous access vs. intra-venous access

intravenous access; IV at the upper limb

ACTIVE COMPARATOR

the OHCA patients receiving IV at the upper limb by paramedics in the field

Device: intra-osseous access vs. intra-venous access

Interventions

intra-osseous access vs. intra-venous accessDEVICE

EZ-IO®: The Arrow® Intraosseous Vascular Access System from Teleflex IV-catheter: form local qualified manufactures

Also known as: EZ-IO® vs. IV-catheter
intra-osseous access, IO at the humeral siteintravenous access; IV at the upper limb

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Out-of-hospital cardiac arrest (OHCA) activated Taipei EMS ALS team (EMTP)
  • Adult ≥ 20 years old

You may not qualify if:

  • OHCA patients with signs of obvious death, e.g. rigor mortis
  • Existing do-not-attempt-resuscitation order
  • Patients with cardiac arrest en route to the hospital
  • OHCA patients with successful vascular access before EMTP arrival
  • OHCA patients with a canceled ambulance call or being transported to the hospital before EMTP arrival
  • OHCA patients with known or suspected pregnancy
  • OHCA patients with traumatic cause of cardiac arrest
  • OHCA patients with known or suspected \< 20 years old, or \> 80 years old
  • OHCA patients with contraindications to IO access or IV access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (6)

  • Petitpas F, Guenezan J, Vendeuvre T, Scepi M, Oriot D, Mimoz O. Use of intra-osseous access in adults: a systematic review. Crit Care. 2016 Apr 14;20:102. doi: 10.1186/s13054-016-1277-6.

    PMID: 27075364BACKGROUND

  • Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available.

    PMID: 26472995BACKGROUND

  • Kawano T, Grunau B, Scheuermeyer FX, Gibo K, Fordyce CB, Lin S, Stenstrom R, Schlamp R, Jenneson S, Christenson J. Intraosseous Vascular Access Is Associated With Lower Survival and Neurologic Recovery Among Patients With Out-of-Hospital Cardiac Arrest. Ann Emerg Med. 2018 May;71(5):588-596. doi: 10.1016/j.annemergmed.2017.11.015. Epub 2018 Jan 6.

    PMID: 29310869BACKGROUND

  • Feinstein BA, Stubbs BA, Rea T, Kudenchuk PJ. Intraosseous compared to intravenous drug resuscitation in out-of-hospital cardiac arrest. Resuscitation. 2017 Aug;117:91-96. doi: 10.1016/j.resuscitation.2017.06.014. Epub 2017 Jun 16.

    PMID: 28629995BACKGROUND

  • Mody P, Brown SP, Kudenchuk PJ, Chan PS, Khera R, Ayers C, Pandey A, Kern KB, de Lemos JA, Link MS, Idris AH. Intraosseous versus intravenous access in patients with out-of-hospital cardiac arrest: Insights from the resuscitation outcomes consortium continuous chest compression trial. Resuscitation. 2019 Jan;134:69-75. doi: 10.1016/j.resuscitation.2018.10.031. Epub 2018 Nov 1.

    PMID: 30391366BACKGROUND

  • Ko YC, Lin HY, Huang EP, Lee AF, Hsieh MJ, Yang CW, Lee BC, Wang YC, Yang WS, Chien YC, Sun JT, Ma MH, Chiang WC. Intraosseous versus intravenous vascular access in upper extremity among adults with out-of-hospital cardiac arrest: cluster randomised clinical trial (VICTOR trial). BMJ. 2024 Jul 23;386:e079878. doi: 10.1136/bmj-2024-079878.

    PMID: 39043416DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Wen-Chu Chiang, PhD

    Dept. of Emergency Medicine, NTUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The intervention (IO vs IV route) on the patients with out-of-hospital cardiac arrest can not be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 22, 2019

Study Start

July 6, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)