CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 182 enrolled
Drug / intervention
Intravenous access during OHCA +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01119807
NCT01119807N/ACompleted

Intraosseous Versus Intravenous Vascular Access During Cardiac Arrest

Wake Forest University Health Sciences·interventional·Posted May 10, 2010·Updated Jun 3, 2022

In Brief

A clinical study evaluating Intravenous access during OHCA, Humeral IO insertion, and 1 other intervention for Cardiac Arrest. Completed, enrolled 182 participants across 1 site.

Detailed Summary

The objective of this study will be to compare humeral and tibial IO needle insertions to peripheral IV access during cardiac arrest. Hypothesis There is a difference in first attempt success of tibial IOs compared to humeral IOs or peripheral IV among cardiac arrest patients. This was a randomized trial of adult patients experiencing a medical OOHCA where resuscitation efforts were initiated. Patients were randomized to 1 of 3 routes of vascular access. Prior to every shift, paramedics were distributed a randomly selected note card indicating the prescribed route for vascular access: tibial IO, humeral IO, or peripheral IV. The selected method applied to the first attempt at vascular access only. Paramedics received intensive training and exposure to all three methods prior to study initiation. The primary outcome was first attempt success defined as secure needle position in the marrow cavity or a peripheral vein with normal fluid flow. Needle dislodgement during resuscitation was counted as a failure to maintain vascular access. In order to detect a statistical difference in the frequency of first attempt success a minimum of 50 patients for each arm of the study were needed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Arrest
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2010
Enrollment StartMay 1, 2010
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.1 years ago

Interventions

Intravenous access during OHCAdevice

First attempt will be a peripheral IV in the AC. If this fails, second attempt will be a tibial IO, followed by a humeral IO when indicated.

Humeral IO insertiondevice

First attempt will be a humeral IO. Second attempt should occur at the tibia if the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs as determined by the paramedic.

TIbial IO insertiondevice

First attempt will be a tibial IO. Second attempt should occur on the opposite tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as selected by the paramedic.