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| Name | Class |
|---|---|
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
| Teleflex | INDUSTRY |
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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".
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intra-osseous access, IO at the humeral site | Experimental | the OHCA patients receiving IO at the humeral site by paramedics in the field |
|
| intravenous access; IV at the upper limb | Active Comparator | the OHCA patients receiving IV at the upper limb by paramedics in the field |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-osseous access vs. intra-venous access | Device | EZ-IO®: The Arrow® Intraosseous Vascular Access System from Teleflex IV-catheter: form local qualified manufactures |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| survival to admission |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen-Chu Chiang, PhD | Dept. of Emergency Medicine, NTUH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27075364 | Background | 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. | |
| 26472995 | Background | 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. |
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randomized clinical trial
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The intervention (IO vs IV route) on the patients with out-of-hospital cardiac arrest can not be masked.
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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 |
| 29310869 | Background | 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. |
| 28629995 | Background | 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. |
| 30391366 | Background | 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. |
| 39043416 | Derived | 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. |
| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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