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

NCT05205031 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 00003
• Study Type: interventional
• Target: 1,479
• Locations: 1 country
• Sites: 5

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.

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Survival

  30 days after the cardiac arrest

• Favorable neurological outcome

  30 days after the cardiac arrest

Study Arms (2)

Intravenous

ACTIVE COMPARATOR

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

Intraosseous

EXPERIMENTAL

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

Interventions

Intraosseous access DEVICE

Needle placed in the bone marrow.

Intraosseous

Intravenous DEVICE

Needle placed in a vein.

Intravenous

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out-of-hospital cardiac arrest
• Age ≥ 18 years
• Indication for intravenous or intraosseous vascular access during cardiac arrest

You may not qualify if:

• 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

Sponsors & Collaborators

• Lars Wiuff Andersen: lead
• Central Denmark Region: collaborator
• University of Aarhus: collaborator

Study Sites (5)

Emergency Medical Services, the North Denmark Region

Aalborg, 9000, Denmark

Location

Prehospital Emergency Medical Services, Central Denmark Region

Aarhus N, 8200, Denmark

Location

Copenhagen Emergency Medical Services, the Capital Region of Denmark

Ballerup Municipality, 2750, Denmark

Location

The Prehospital Center, Region Zealand

Næstved, 4700, Denmark

Location

Emergency Medical Services, the Region of Southern Denmark

Vejle, 7100, Denmark

Location

Related Publications (2)

• Vallentin MF, Holmberg MJ, Granfeldt A, Klitgaard TL, Mikkelsen S, Folke F, Christensen HC, Povlsen AL, Petersen AH, Winther S, Frilund LW, Meilandt C, Winther KB, Bach A, Dissing TH, Terkelsen CJ, Christensen S, Rasmussen LK, Mortensen LR, Loldrup ML, Elkmann T, Nielsen AG, Runge C, Klaestrup E, Holm JH, Bak M, Nielsen LR, Pedersen M, Kjaergaard-Andersen G, Hansen PM, Brochner AC, Christensen EF, Nielsen FM, Nissen CG, Bjorn JW, Burholt P, Obling LER, Holle SLD, Russell L, Alstrom H, Hestad S, Fogtmann TH, Hove Buciek JU, Jakobsen K, Krag M, Sandgaard M, Sindberg B, Andersen LW. Intraosseous vs. intravenous access during out-of-hospital cardiac arrest: a Bayesian secondary analysis of a randomised clinical trial. Resuscitation. 2025 Jul;212:110634. doi: 10.1016/j.resuscitation.2025.110634. Epub 2025 May 17.

  PMID: 40348355 DERIVED

• Vallentin MF, Granfeldt A, Klitgaard TL, Mikkelsen S, Folke F, Christensen HC, Povlsen AL, Petersen AH, Winther S, Frilund LW, Meilandt C, Holmberg MJ, Winther KB, Bach A, Dissing TH, Terkelsen CJ, Christensen S, Kirkegaard Rasmussen L, Mortensen LR, Loldrup ML, Elkmann T, Nielsen AG, Runge C, Klaestrup E, Holm JH, Bak M, Nielsen LR, Pedersen M, Kjaergaard-Andersen G, Hansen PM, Brochner AC, Christensen EF, Nielsen FM, Nissen CG, Bjorn JW, Burholt P, Obling LER, Holle SLD, Russell L, Alstrom H, Hestad S, Fogtmann TH, Buciek JUH, Jakobsen K, Krag M, Sandgaard M, Sindberg B, Andersen LW. Intraosseous or Intravenous Vascular Access for Out-of-Hospital Cardiac Arrest. N Engl J Med. 2025 Jan 23;392(4):349-360. doi: 10.1056/NEJMoa2407616. Epub 2024 Oct 31.

  PMID: 39480221 DERIVED

Related Links

• Trial website

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 24, 2022
• Study Start: March 1, 2022
• Primary Completion: May 5, 2024
• Study Completion: May 5, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

DK (5)