Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital (IVIO)

Lars Wiuff Andersen

Status and phase: Active, not recruiting; Phase 4

Conditions: Cardiac Arrest

Treatments: Device: Intraosseous access; Device: Intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT05205031

00003

Details and patient eligibility

About

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.

Enrollment: 1,479 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,479 participants in 2 patient groups

Intravenous

Active Comparator group

Description:

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.

Treatment:

Device: Intravenous

Intraosseous

Experimental group

Description:

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.

Treatment:

Device: Intraosseous access