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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1479 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-05-05

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.

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Detailed Description

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Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Intravenous

Intervention Type DEVICE

Needle placed in a vein.

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.

Group Type EXPERIMENTAL

Intraosseous access

Intervention Type DEVICE

Needle placed in the bone marrow.

Interventions

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Intraosseous access

Needle placed in the bone marrow.

Intervention Type DEVICE

Intravenous

Needle placed in a vein.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No