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

Last updated: September 9, 2024
Sponsor: Lars Wiuff Andersen
Overall Status: Active - Not Recruiting

Phase

4

Condition

Circulation Disorders

Heart Failure

Heart Attack (Myocardial Infarction)

Treatment

Intravenous

Intraosseous access

Clinical Study ID

NCT05205031
00003
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Out-of-hospital cardiac arrest

  2. Age ≥ 18 years

  3. Indication for intravenous or intraosseous vascular access during cardiac arrest

Exclusion

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 thefirst trial-participating unit arrives on site

Study Design

Total Participants: 1479
Treatment Group(s): 2
Primary Treatment: Intravenous
Phase: 4
Study Start date:
March 01, 2022
Estimated Completion Date:
May 05, 2025

Connect with a study center

  • Emergency Medical Services, the North Denmark Region

    Aalborg, 9000
    Denmark

    Site Not Available

  • Prehospital Emergency Medical Services, Central Denmark Region

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Copenhagen Emergency Medical Services, the Capital Region of Denmark

    Ballerup, 2750
    Denmark

    Site Not Available

  • The Prehospital Center, Region Zealand

    Næstved, 4700
    Denmark

    Site Not Available

  • Emergency Medical Services, the Region of Southern Denmark

    Vejle, 7100
    Denmark

    Site Not Available

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