Cardiac Arrest
Conditions
Brief summary
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.
Interventions
Needle placed in the bone marrow.
Needle placed in a vein.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained return of spontaneous circulation | 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
| Measure | Time frame | Description |
|---|---|---|
| Survival | 30 days after the cardiac arrest | — |
| Favorable neurological outcome | 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). |
Countries
Denmark