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

Primary Purpose

Cardiac Arrest

Status

Recruiting

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Intraosseous access

Intravenous

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Emergency Medical Services, the North Denmark RegionRecruiting
Prehospital Emergency Medical Services, Central Denmark RegionRecruiting
Copenhagen Emergency Medical Services, the Capital Region of Denmark
Emergency Medical Services, the Region of Southern DenmarkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intravenous

Intraosseous

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Sustained return of spontaneous circulation

Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes

Secondary Outcome Measures

Survival

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).

Full Information

NCT ID

NCT05205031

First Posted

January 11, 2022

Last Updated

August 10, 2023

Sponsor

Lars Wiuff Andersen

Collaborators

Central Denmark Region, University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT05205031

Brief Title

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

Acronym

IVIO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

February 28, 2024 (Anticipated)

Study Completion Date

February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lars Wiuff Andersen

Collaborators

Central Denmark Region, University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

1262 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravenous

Arm Type

Active Comparator

Arm Description

Arm Title

Intraosseous

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Intraosseous access

Intervention Description

Needle placed in the bone marrow.

Intervention Type

Device

Intervention Name(s)

Intravenous

Intervention Description

Needle placed in a vein.

Primary Outcome Measure Information:

Title

Sustained return of spontaneous circulation

Description

Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes

Time Frame

Before or after hospital arrival (up to 2 hours after the cardiac arrest)

Secondary Outcome Measure Information:

Title

Survival

Time Frame

30 days after the cardiac arrest

Title

Favorable neurological outcome

Description

Time Frame

30 days after the cardiac arrest

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lars W Andersen

Phone

+4551781511

lwandersen@clin.au.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Mikael F Vallentin

Phone

+4591174323

mikvog@rm.dk

Facility Information:

Facility Name

Emergency Medical Services, the North Denmark Region

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Klitgaard

Facility Name

Prehospital Emergency Medical Services, Central Denmark Region

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mikael F Vallentin, MD

Facility Name

Copenhagen Emergency Medical Services, the Capital Region of Denmark

City

Ballerup

ZIP/Postal Code

2750

Country

Denmark

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fredrik Folke

Facility Name

Emergency Medical Services, the Region of Southern Denmark

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Søren Mikkelsen

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing.

Links:

URL

https://www.ivio.dk/

Description

Trial website

Learn more about this trial

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

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