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

NCT05205031 · tracked via the Priya Life Science Denmark tracker

Sponsor

Lars Wiuff Andersen

Phase

Phase 4

Started

2022-03-01

Last updated

2024-09-19

Condition(s) studied

Cardiac Arrest

Investigational drug(s) / intervention(s)

Intraosseous accessIntravenous

Intraosseous access: Needle placed in the bone marrow.

Intravenous: Needle placed in a vein.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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

Trial sites (5)

Facility	City	Region
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

More Lars Wiuff Andersen trials in Denmark

Bicarbonate for In-Hospital Cardiac Arrest Active, not recruiting

Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest Recruiting

Other trials for the same condition

COMPuter-assisted Self-training to Improve EXecutive Function Recruiting

Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest Active, not recruiting

Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest Recruiting

Bicarbonate for In-Hospital Cardiac Arrest Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05205031 on ClinicalTrials.gov ↗ ← All trials in Denmark