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

Phase 4

Active, not recruiting

• Conditions: Cardiac Arrest

• Registration Number: NCT05205031
• Lead Sponsor: Lars Wiuff Andersen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-24
• Study Start: 2022-03-01
• Primary Completion: 2024-05-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1479

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Favorable neurological outcome	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).
Survival	30 days after the cardiac arrest

Trial Locations

Locations (5)

The Prehospital Center, Region Zealand; 🇩🇰 Næstved, 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, Denmark