Venous Injection Compared To intraOsseous Injection During Resuscitation of Patients With Out-of-hospital Cardiac Arrest (VICTOR)
Primary Purpose
Emergency Medical Service, Out-of-Hospital Cardiac Arrest, Vascular Access
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
intra-osseous access vs. intra-venous access
Sponsored by
About this trial
This is an interventional treatment trial for Emergency Medical Service
Eligibility Criteria
Inclusion Criteria:
- Out-of-hospital cardiac arrest (OHCA) activated Taipei EMS ALS team (EMTP)
- Adult ≥ 18 years old
- Non-traumatic cause of cardiac arrest
Exclusion Criteria:
- Patients with signs of obvious death, e.g. rigor mortis
- Existing do-not-attempt-resuscitation order
- OHCA patients with contraindications to IO access or IV access
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intra-osseous access, IO at the humeral site
intravenous access; IV at the upper limb
Arm Description
the OHCA patients receiving IO at the humeral site by paramedics in the field
the OHCA patients receiving IV at the upper limb by paramedics in the field
Outcomes
Primary Outcome Measures
the rate of survival to hospital discharge
OHCA patients with survival to hospital discharge
Secondary Outcome Measures
the time and rate of return of spontaneous circulation (*ROSC*)
the time and rate of return of spontaneous circulation (*ROSC*), prehospital ROSC
survival to admission
survival to admission, or in some overcrodwed hospital, surrogated by sustained ROSC > 2hrs
favorable neurologic survival staus
favorable neurologic survival staus defined by CPC 1 & 2 level (CPC: cerebral performance categlory)
Full Information
NCT ID
NCT04135547
First Posted
October 16, 2019
Last Updated
October 19, 2023
Sponsor
National Taiwan University Hospital
Collaborators
Ministry of Science and Technology, Taiwan, Teleflex
1. Study Identification
Unique Protocol Identification Number
NCT04135547
Brief Title
Venous Injection Compared To intraOsseous Injection During Resuscitation of Patients With Out-of-hospital Cardiac Arrest
Acronym
VICTOR
Official Title
Venous Injection Compared To intraOsseous Injection During Resuscitation of Patients With Out-of-hospital Cardiac Arrest (The VICTOR Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Ministry of Science and Technology, Taiwan, Teleflex
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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".
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:
. 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.
. 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.
. 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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Medical Service, Out-of-Hospital Cardiac Arrest, Vascular Access, Intraosseous Access, Intravenous Access
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial
Masking
None (Open Label)
Masking Description
The intervention (IO vs IV route) on the patients with out-of-hospital cardiac arrest can not be masked.
Allocation
Randomized
Enrollment
1732 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intra-osseous access, IO at the humeral site
Arm Type
Experimental
Arm Description
the OHCA patients receiving IO at the humeral site by paramedics in the field
Arm Title
intravenous access; IV at the upper limb
Arm Type
Active Comparator
Arm Description
the OHCA patients receiving IV at the upper limb by paramedics in the field
Intervention Type
Device
Intervention Name(s)
intra-osseous access vs. intra-venous access
Other Intervention Name(s)
EZ-IO® vs. IV-catheter
Intervention Description
EZ-IO®: The Arrow® Intraosseous Vascular Access System from Teleflex IV-catheter: form local qualified manufactures
Primary Outcome Measure Information:
Title
the rate of survival to hospital discharge
Description
OHCA patients with survival to hospital discharge
Time Frame
up to 1 month after the OHCA event
Secondary Outcome Measure Information:
Title
the time and rate of return of spontaneous circulation (*ROSC*)
Description
the time and rate of return of spontaneous circulation (*ROSC*), prehospital ROSC
Time Frame
up to 1 week after the OHCA event
Title
survival to admission
Description
survival to admission, or in some overcrodwed hospital, surrogated by sustained ROSC > 2hrs
Time Frame
up to 1 week after the OHCA event
Title
favorable neurologic survival staus
Description
favorable neurologic survival staus defined by CPC 1 & 2 level (CPC: cerebral performance categlory)
Time Frame
up to 1 month after the OHCA event
Other Pre-specified Outcome Measures:
Title
subgroups analysis
Description
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.
Time Frame
through study completion, an average of half a year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Chu Chiang, PhD
Organizational Affiliation
Dept. of Emergency Medicine, NTUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27075364
Citation
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.
Results Reference
background
PubMed Identifier
26472995
Citation
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.
Results Reference
background
PubMed Identifier
29310869
Citation
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.
Results Reference
background
PubMed Identifier
28629995
Citation
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.
Results Reference
background
PubMed Identifier
30391366
Citation
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.
Results Reference
background
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Venous Injection Compared To intraOsseous Injection During Resuscitation of Patients With Out-of-hospital Cardiac Arrest
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