Venous Injection Compared To intraOsseous Injection During Resuscitation of Patients With Out-of-hospital Cardiac Arrest (VICTOR)

Venous Injection Compared To intraOsseous Injection During Resuscitation of Patients With Out-of-hospital Cardiac Arrest (The VICTOR Trial)

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".

Study Overview

• Status: Completed
• Conditions: Vascular Access; Out-of-Hospital Cardiac Arrest; Intraosseous Access; Emergency Medical Service; Intravenous Access
• Intervention / Treatment: Device: intra-osseous access vs. intra-venous access

Detailed Description

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 hospital care is 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, recently became the focus under debate.

Theoretically, IO access provides a rapidly established way to administrate medication and fluid to patients (Reference 1) and has been adopted in many acute care societies and organizations including current resuscitation guidelines (Reference 2). However, some of the recent publications questioned the outcomes of OHCA patients receiving the IO route comparing to the IV route (References 3-5). Studies showed non-different or negative outcomes of patients receiving the IO route has been severely biased through the inherent inadequacy of retrospective design (References 3-5). The three major problems of those studies were:

1. . Time to vascular access cannot be adjusted. In many EMS, IO access was allowed only after one or two failed attempts of IV route. This led to a significant selection bias.
2. . The location of vascular access was not accurately reported. As we know, medications through upper limbs arrive at the heart sooner than the lower limbs. Many paramedics tend to insert the IO needle in tibia but to inset IV catheters in the forearm vein.
3. . Post-hoc analysis with old data over 5 to 10 years. Two of the three studies were the post-hoc analysis from the data of previous studies which was conducted from 2007 to 2010 when cardiopulmonary resuscitation quality and teamwork (i.e. important confounding factors to OHCA survival) were not that emphasized and recorded.

Hence, the investigators designed the study to determine the comparative effectiveness of IO access vs IV access in patients with OHCA by a randomized controlled trial (*RCT*) in Taipei EMS. In this 2-year research plan, we will conduct a prehospital RCT to address the following question: In adult patients with non-traumatic cause of OHCA resuscitated by emergency medical technician paramedic in the prehospital setting, will receiving IO access cause a better chance of survival to discharge, sustained recovery of spontaneous circulation, and other survival outcomes like neurologically favorable status, comparing to those who receiving IV access.

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".

• Study Type: Interventional
• Enrollment (Actual): 1732
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intra-osseous access, IO at the humeral site; the OHCA patients receiving IO at the humeral site by paramedics in the field	Device: intra-osseous access vs. intra-venous access; EZ-IO®: The Arrow® Intraosseous Vascular Access System from Teleflex IV-catheter: form local qualified manufactures; Other Names: EZ-IO® vs. IV-catheter
Active Comparator: intravenous access; IV at the upper limb; the OHCA patients receiving IV at the upper limb by paramedics in the field	Device: intra-osseous access vs. intra-venous access; EZ-IO®: The Arrow® Intraosseous Vascular Access System from Teleflex IV-catheter: form local qualified manufactures; Other Names: EZ-IO® vs. IV-catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of survival to hospital discharge	OHCA patients with survival to hospital discharge	up to 1 month after the OHCA event

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival to admission	survival to admission, or in some overcrodwed hospital, surrogated by sustained ROSC > 2hrs	up to 1 week after the OHCA event
favorable neurologic survival staus	favorable neurologic survival staus defined by CPC 1 & 2 level (CPC: cerebral performance categlory)	up to 1 month after the OHCA event
the time and rate of return of spontaneous circulation (*ROSC*)	the time and rate of return of spontaneous circulation (*ROSC*), prehospital ROSC	up to 1 week after the OHCA event

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
subgroups analysis	including subgroups with different ages, sexs, witnessed status, initial presenting rhythm (shockable vs. non-shockable), bystander CPR, response intervals, time to vascular access, and time to first-dose epinephrine.	through study completion, an average of half a year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Ministry of Science and Technology, Taiwan; Teleflex
• Investigators: Principal Investigator: Wen-Chu Chiang, PhD, Dept. of Emergency Medicine, NTUH

Publications and helpful links

General Publications

• 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. Erratum In: Circulation. 2015 Dec 15;132(24):e385.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 20, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Emergencies; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 201904039RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes