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NCT Number: NCT05205031

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emergency Medical Services, the North Denmark Region, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Out-of-hospital cardiac arrest
  • Age ≥ 18 years
  • Indication for intravenous or intraosseous vascular access during cardiac arrest

Exclusion criteria

  • Blunt or penetrating traumatic cardiac arrest
  • Prior enrollment in the trial
  • Intravenous or intraosseous vascular access already in place and working when the first trial-participating unit arrives on site

Treatment and study plan

Intraosseous access

Device

Needle placed in the bone marrow.

Intravenous

Device

Needle placed in a vein.

Primary outcomes

  1. Sustained return of spontaneous circulation

    Time frame: 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

Secondary outcomes

  1. Survival

    Time frame: 30 days after the cardiac arrest

  2. Favorable neurological outcome

    Time frame: 30 days after the cardiac arrest

    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).

Sponsors and collaborators

Lead sponsor

Lars Wiuff Andersen

Other

Collaborators

  • Central Denmark Region
  • University of Aarhus

Registry information

Official study title

Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest - a Randomized Clinical Trial

Acronym: IVIO

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 24, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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