Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05205031
Other study ID # 00003
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2022
Est. completion date February 28, 2025

Study information

Verified date August 2023
Source Aarhus University Hospital
Contact Lars W Andersen
Phone +4551781511
Email lwandersen@clin.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1262
Est. completion date February 28, 2025
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Intraosseous access
Needle placed in the bone marrow.
Intravenous
Needle placed in a vein.

Locations

Country Name City State
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

Sponsors (3)

Lead Sponsor Collaborator
Lars Wiuff Andersen Central Denmark Region, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Survival 30 days after the cardiac arrest
Secondary 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). 30 days after the cardiac arrest
See also
  Status Clinical Trial Phase
Recruiting NCT06048068 - Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events N/A
Recruiting NCT05558228 - Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
Completed NCT03685383 - Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Completed NCT04619498 - Effectiveness of an Interactive Cognitive Support Tablet App to Improve the Management of Pediatric Cardiac Arrest N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT02352350 - Lactate in Cardiac Arrest N/A
Completed NCT03024021 - Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
Completed NCT02275234 - Care After Resuscitation
Completed NCT02247947 - Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome
Completed NCT01972087 - Simulation Training to Improve 911 Dispatcher Identification of Cardiac Arrest N/A
Completed NCT01944605 - Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest N/A
Completed NCT01936597 - Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage N/A
Active, not recruiting NCT01239420 - Norwegian Cardio-Respiratory Arrest Study
Completed NCT00880087 - Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial N/A
Completed NCT01191736 - Ultra-Brief Versus Brief Hands Only CPR Video Training With and Without Psychomotor Skill Practice N/A
Completed NCT00878644 - Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial Phase 3
Completed NCT00729794 - Vasopressin, Epinephrine, and Steroids for Cardiac Arrest Phase 3
Recruiting NCT00441753 - Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest N/A
Completed NCT00347477 - Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest Phase 3

External Links