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

Sponsor

Lars Wiuff Andersen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05205031

Collaborator

Central Denmark Region (Other), University of Aarhus (Other)

762

Enrollment

Location

Arms

Anticipated Duration (Months)

21.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Device: Intraosseous access Device: Intravenous	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

762 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Survival [30 days after the cardiac arrest]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prehospital Emergency Medical Services	Aarhus N	Central Denmark Region	Denmark	8200

Sponsors and Collaborators

Lars Wiuff Andersen
Central Denmark Region
University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Trial website

Publications

None provided.

Responsible Party:

Lars Wiuff Andersen, Associate Professor, Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT05205031

Other Study ID Numbers:

00003

First Posted:

Jan 24, 2022

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Arrest

Study Results

No Results Posted as of Mar 29, 2022