National Taiwan University Hospital
Taipei, 100, Taiwan
NCT Number: NCT04135547
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".
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All sexes
Interventional
Not applicable
Taipei, 100, Taiwan
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:
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".
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EZ-IO®: The Arrow® Intraosseous Vascular Access System from Teleflex IV-catheter: form local qualified manufactures
Other names: EZ-IO® vs. IV-catheter
Time frame: up to 1 month after the OHCA event
OHCA patients with survival to hospital discharge
Time frame: up to 1 week after the OHCA event
the time and rate of return of spontaneous circulation (*ROSC*), prehospital ROSC
Time frame: up to 1 week after the OHCA event
survival to admission, or in some overcrodwed hospital, surrogated by sustained ROSC > 2hrs
Time frame: up to 1 month after the OHCA event
favorable neurologic survival staus defined by CPC 1 & 2 level (CPC: cerebral performance categlory)
Time frame: through study completion, an average of half a year
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.
National Taiwan University Hospital
Other
Venous Injection Compared To intraOsseous Injection During Resuscitation of Patients With Out-of-hospital Cardiac Arrest (The VICTOR Trial)
Acronym: VICTOR
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