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
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
Arm Title
Intraosseous
Arm Type
Experimental
Arm Description
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.
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
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).
Time Frame
30 days after the cardiac arrest
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Email
lwandersen@clin.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mikael F Vallentin
Phone
+4591174323
Email
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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