The IVIO-trial is a randomized clinical trial evaluating intravenous vs. intraosseous vascular access during adult out-of-hospital cardiac arrest. Specifically, when there is no vascular access in place, patients are randomized in a 1:1-ratio to primary attempts at either modality (see Interventions). The flow chart on the right provides an overview of the condition, standard basic care, the interventions as well as the primary and secondary outcomes.
This trial includes unconscious patients that are unable to provide informed consent. Given the urgency of the intervention, it is not possible to obtain consent from a surrogate (e.g. family member). In accordance with European regulations and Danish law, patients are included without prior consent. As soon as possible, consent for future data collection will be obtained from the patient or a surrogate.
The trial has been approved by "De Videnskabsetiske Medicinske Komitéer" (VMK) as well as the Danish Medicines Agency.