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

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ClinicalTrials.gov Identifier: NCT04135547
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborators:
Ministry of Science and Technology, Taiwan
Teleflex
Information provided by (Responsible Party):
National Taiwan University Hospital

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".


Condition or disease Intervention/treatment Phase
Emergency Medical Service Out-of-Hospital Cardiac Arrest Vascular Access Intraosseous Access Intravenous Access Device: intra-osseous access vs. intra-venous access Not Applicable

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".

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled 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.
Primary Purpose: Treatment
Official Title: Venous Injection Compared To intraOsseous Injection During Resuscitation of Patients With Out-of-hospital Cardiac Arrest (The VICTOR Trial)
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: EZ-IO® vs. IV-catheter




Primary Outcome Measures :
  1. the rate of survival to hospital discharge [ Time Frame: up to 1 month after the OHCA event ]
    OHCA patients with survival to hospital discharge


Secondary Outcome Measures :
  1. the rate and time of return of spontaneous circulation (*ROSC*) [ Time Frame: up to 1 week after the OHCA event ]
    the rate of return of spontaneous circulation (*ROSC*) and estimated down time to first ROSC

  2. survival to admission [ Time Frame: up to 1 week after the OHCA event ]
    survival to admission, or in some overcrodwed hospital, surrogated by sustained ROSC > 2hrs

  3. favorable neurologic survival staus [ Time Frame: up to 1 month after the OHCA event ]
    favorable neurologic survival staus defined by CPC 1 & 2 level (CPC: cerebral performance categlory)


Other Outcome Measures:
  1. subgroups analysis [ Time Frame: through study completion, an average of half a year ]
    including subgroups with different ages, initial presenting rhythm (shockable vs. non-shockable), response intervals, time to vascular access, time to first-dose epinephrine, total prehospital epipenrphine dose, and total prehospital fluid amount.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135547


Contacts
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Contact: Wen-Chu Chiang, PhD +886-2-23123456 ext 62831 drchiang.tw@gmail.com

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

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04135547    
Other Study ID Numbers: 201904039RIND
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Emergencies
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases