Clinical trial NCT01742780: Evaluation of Various Methods Used to Identify the Proximal Humerus Intraosseous Vascular Access Site
Official title: A Study Evaluating Insertion Site Identification Methods Used to Establish Intraosseous Vascular Access in the Proximal Humerus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Proximal Humerus Intraosseous Vascular Access
Keywords: Intraosseous Vascular Access
IO Access
IO Vascular Access
EZ-IO
Lead sponsor: Vidacare Corporation
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine if there is one method of identifying the proximal humerus intraosseous vascular access site that is easier for clinicians to use, out of the 4 methods being evaluated.


Eligibility criteria: Inclusion Criteria Device Operators:

* Recent/current experience in the medical field as a practicing clinician.
* Currently licensed/certified Emergency Medicine Technician, paramedic, or nurse
* Have had no formal training on use of the proximal humerus intraosseous insertion site.

Exclusion Criteria Device Operators:

There is no exclusion criteria

Inclusion Criteria Healthy Volunteers

* Age 21 years or older.
* Has no amputation of the upper extremities.
* Able to lay flat on table for up to 2 hours.
* Self-reported as healthy.

Exclusion Criteria Healthy Volunteers:

* Have an active infection in the body
* Imprisoned
* Pregnant
* Cognitively impaired
* Fracture in humerus, or significant trauma to the site
* Excessive tissue and/or absence of adequate anatomical landmarks in humerus
* Infection in target area
* Humeral intraosseous insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus
* Current use of anti-coagulants

Primary outcomes:
measure: Ease of use score
timeFrame: Within 10 minutes of procedure
measure: Level of confidence score
timeFrame: within 10 minutes of procedure
measure: Site identification success/failure
timeFrame: within 10 minutes of the procedure
measure: Time to intraosseous catheter placement
timeFrame: within 10 minutes of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Spring Branch
country: United States
facility: Bulverde-Spring Branch EMS
state: Texas
Study officials:
affiliation: Vidacare Corporation
name: Larry J Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reades R, Studnek JR, Vandeventer S, Garrett J. Intraosseous versus intravenous vascular access during out-of-hospital cardiac arrest: a randomized controlled trial. Ann Emerg Med. 2011 Dec;58(6):509-16. doi: 10.1016/j.annemergmed.2011.07.020.
citation: Reades R, Studnek JR, Garrett JS, Vandeventer S, Blackwell T. Comparison of first-attempt success between tibial and humeral intraosseous insertions during out-of-hospital cardiac arrest. Prehosp Emerg Care. 2011 Apr-Jun;15(2):278-81. doi: 10.3109/10903127.2010.545479. Epub 2011 Jan 28.
citation: Wampler D, Schwartz D, Shumaker J, Bolleter S, Beckett R, Manifold C. Paramedics successfully perform humeral EZ-IO intraosseous access in adult out-of-hospital cardiac arrest patients. Am J Emerg Med. 2012 Sep;30(7):1095-9. doi: 10.1016/j.ajem.2011.07.010. Epub 2011 Oct 24.