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

Study Overview
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Brief Summary
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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.

Official Title
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Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest - A Randomized Clinical Trial

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: Intraosseous access
* Device: Intravenous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-of-hospital cardiac arrest Age ≥ 18 years Indication for intravenous or intraosseous vascular access during cardiac arrest Exclusion Criteria: Blunt or penetrating traumatic cardiac arrest Prior enrollment in the trial Intravenous or intraosseous vascular access already in place and working when the first trial-participating unit arrives on site

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous<br>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. | Device: Intravenous<br>* Needle placed in a vein.<br>|
| Experimental: Intraosseous<br>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. | Device: Intraosseous access<br>* Needle placed in the bone marrow.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 30 days after the cardiac arrest | 
| Favorable neurological outcome | 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). | 30 days after the cardiac arrest |