Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital

Overview

The "Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest (IVIO)"-trial is an investigator-initiated, randomized, parallel group, patient and outcome assessor-blinded, superiority trial of intravenous vs. intraosseous vascular access during adult out-of-hospital cardiac arrest. The intraosseous group will be further randomized to humeral vs. tibial access. The trial will be conducted in the Central Denmark Region. The primary outcome will be sustained return of spontaneous circulation, and 762 patients will be included. Key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.

Full Title of Study: “Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest – A Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 28, 2024

Interventions

  • Device: Intraosseous access
    • Needle placed in the bone marrow.
  • Device: Intravenous
    • Needle placed in a vein.

Arms, Groups and Cohorts

  • Active Comparator: Intravenous
    • The intervention will consist of attempts to successfully establish a peripheral intravenous access during the cardiac arrest. The prehospital clinician will be required to attempt the intervention a minimum of two times.
  • Experimental: Intraosseous
    • The intervention will consist of attempts to successfully establish an intraosseous access during the cardiac arrest. The prehospital clinician will be required to attempt the intervention a minimum of two times.

Clinical Trial Outcome Measures

Primary Measures

  • Sustained return of spontaneous circulation
    • Time Frame: Before or after hospital arrival (up to 2 hours after the cardiac arrest)
    • Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes

Secondary Measures

  • Survival
    • Time Frame: 30 days after the cardiac arrest
  • Favorable neurological outcome
    • Time Frame: 30 days after the cardiac arrest
    • Neurological outcome will be assessed with the modified Rankin Scale (mRS) which is a scale from 0 to 6 assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. The scale will will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).

Participating in This Clinical Trial

Inclusion Criteria

1. Out-of-hospital cardiac arrest 2. Age ≥ 18 years 3. Indication for intravenous or intraosseous vascular access during cardiac arrest Exclusion Criteria:

1. Blunt or penetrating traumatic cardiac arrest 2. Prior enrollment in the trial 3. Intravenous or intraosseous vascular access already in place and working when the first trial-participating unit arrives on site

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lars Wiuff Andersen
  • Collaborator
    • Central Denmark Region
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Lars Wiuff Andersen, Associate Professor – Aarhus University Hospital
  • Overall Contact(s)
    • Lars W Andersen, +4551781511, lwandersen@clin.au.dk

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