N/A
N=182
Intraosseous Versus Intravenous Vascular Access During Cardiac Arrest
Cardiac Arrest
Bottom Line
View on ClinicalTrials.gov: NCT01119807 ↗Enrolled (actual)
182
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: First Attempt Success Rate Between the Tibial IO, Humeral IO, and Peripheral IV. — 26; 17; 58 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intravenous access during OHCA (Device); Humeral IO insertion (Device); TIbial IO insertion (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY First Attempt Success Rate Between the Tibial IO, Humeral IO, and Peripheral IV. |
26; 17; 58 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All cardiac arrests of a medical nature in patients greater than or equal to 18 years of age occuring in Mecklenburg county, NC.
Exclusion Criteria
- Traumatic cardiac arrests - different prehospital protocols exist for resuscitations involving traumatic arrests (i.e. motor vehicle accidents, motorcycle accidents, falls, and penetrating injuries including stabbings and gunshot wounds).
- Cardiac arrests due to hemorrhage - for the purposes of this study, such arrests are not considered to be of a "medical etiology" since massive blood loss is the contributing factor and only rapid volume resuscitation is indicated.
- Cardiac arrests involving children or young adults - any patient less than 18 years of age will be excluded as different prehospital protocols exist for children in cardiac arrest. Age verification will occur upon data collection using patient date of birth when available. Any data collected from a patient found to be less than 18 years of age after resuscitation, will also be excluded from data analysis.
- Patients with established vascular access prior to cardiac arrest - patients who deteriorate during transport into cardiac arrest but already have a peripheral IV or IO needle established will be excluded from the study. Randomization cannot be applied to these encounters as vascular access has already been selected and documentation by a sole provider is not possible during transport.
- Patients with a Do Not Resuscitate (DNR) - in some circumstances, cardiopulmonary resuscitation is initially performed on patients until a DNR order is produced. These patients will be excluded from the study as the full protocol cannot be implemented.
Data sourced from ClinicalTrials.gov (NCT01119807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.