Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital (IVIO)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: Intravenous; Device: Intraosseous access

• Study Type: Interventional
• Enrollment (Actual): 1479
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Emergency Medical Services, the North Denmark Region
  • Aarhus N, Denmark, 8200
    • Prehospital Emergency Medical Services, Central Denmark Region
  • Ballerup, Denmark, 2750
    • Copenhagen Emergency Medical Services, the Capital Region of Denmark
  • Vejle, Denmark, 7100
    • Emergency Medical Services, the Region of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous; The intervention will consist of attempts to successfully establish a peripheral intravenous access during the cardiac arrest. The prehospital clinician will be required to attempt the intervention a minimum of two times.	Device: Intravenous; Needle placed in a vein.
Experimental: Intraosseous; The intervention will consist of attempts to successfully establish an intraosseous access during the cardiac arrest. The prehospital clinician will be required to attempt the intervention a minimum of two times.	Device: Intraosseous access; Needle placed in the bone marrow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival		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).	30 days after the cardiac arrest

Collaborators and Investigators

• Sponsor: Lars Wiuff Andersen
• Collaborators: University of Aarhus; Central Denmark Region

Publications and helpful links

Helpful Links

• Trial website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): May 5, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No