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NCT05205031 Clinical Trial

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

Cardiac Arrest Clinical Trial

— IVIO  

Official title:
Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest - A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05205031
Other study ID # 00003
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2022
Est. completion date February 28, 2025

Study information
Verified date June 2024
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1479
Est. completion date February 28, 2025
Est. primary completion date May 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Intraosseous access
Needle placed in the bone marrow.
• Intravenous
Needle placed in a vein.

Locations
Country Name City State
Denmark 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
Denmark Emergency Medical Services, the Region of Southern Denmark Vejle

Sponsors (3)
Lead Sponsor Collaborator
Lars Wiuff Andersen Central Denmark Region, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sustained return of spontaneous circulation Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes Before or after hospital arrival (up to 2 hours after the cardiac arrest)
Secondary Survival 30 days after the cardiac arrest
Secondary 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). 30 days after the cardiac arrest
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