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

Phase 4Active Not RecruitingNCT05205031

Lars Wiuff Andersen1,479 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,479

Conditions

Cardiac Arrest

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Emergency Medical Services, the North Denmark Region

Aalborg, Denmark

Prehospital Emergency Medical Services, Central Denmark Region

Aarhus N, Denmark

Copenhagen Emergency Medical Services, the Capital Region of Denmark

Ballerup Municipality, Denmark

The Prehospital Center, Region Zealand

Næstved, Denmark

Emergency Medical Services, the Region of Southern Denmark

Vejle, Denmark

Outcomes

Primary Outcomes

Sustained return of spontaneous circulation

Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes

Time frame: Before or after hospital arrival (up to 2 hours after the cardiac arrest)

Secondary Outcomes

Survival

Time frame: 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).

Time frame: 30 days after the cardiac arrest