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

Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest - a Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05205031
Acronym
IVIO
Enrollment
1479
Registered
2022-01-24
Start date
2022-03-01
Completion date
2025-05-05
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

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

Central Denmark Region
CollaboratorOTHER
University of Aarhus
CollaboratorOTHER
Lars Wiuff Andersen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Sustained return of spontaneous circulationBefore 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

MeasureTime frameDescription
Survival30 days after the cardiac arrest
Favorable neurological outcome30 days after the cardiac arrestNeurological 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026