Skip to main content
OpenTrials
Completed

NCT Number: NCT01742780

Evaluation of Various Methods Used to Identify the Proximal Humerus Intraosseous Vascular Access Site

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vascular Access

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bulverde-Spring Branch EMS

Spring Branch, Texas, 78070, United States

About this study

This was a non-controlled study using licensed/certified EMT/paramedics and licensed nurses as device operator subjects identifying the proximal humerus IO insertion site and inserting the IO catheter in healthy adult volunteers. Forty (40) clinicians with no prior training on establishing IO vascular access in the proximal humerus IO insertion site were enrolled in the study as device operator subjects. Twenty (20) healthy adult volunteers were enrolled in the study to have IO vascular access established bilaterally in the proximal humerus with one device operator accessing one of the subject's arms, according to their assigned method for identifying the proximal humerus intraosseous vascular access site.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraosseous Vascular Access

Other

Intraosseous vascular access in the proximal humerus.

Primary outcomes

  1. Ease of Use Score

    Time frame: Within 10 minutes of procedure

    Device operators will score their perceived Ease of Use for their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The Ease of Use scale scores range from 0 to 10, where 0=extremely difficult and 10=extremely easy. Higher scores indicate greater ease of use.

  2. Level of Confidence Score

    Time frame: within 10 minutes of procedure

    Device operators scored their perceived Level of Confidence with their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The Level of Confidence scale scores range from 0 to 10, where. 0=no confidence and 10=extremely confident. Higher scores indicate greater level of confidence.

  3. Proximal Humerus Intraosseous (IO) Insertion Site Placement Score

    Time frame: within 10 minutes of the procedure

    The ability of the device operator to insert the Intraosseous device into the "ideal target area" was scored using an accuracy scoring scale. The "ideal target area" was defined as the center of the greater tubercle. The following scoring scale ranging from 0 to 3 was used. 3= center of the greater tubercle; 2=sightly off-center of the greater tubercle, 1=borderline of the greater tubercle, and 0=completely outside the greater tubercle. Higher scores indicate better insertion position.

  4. Time to Intraosseous (IO) Catheter Placement

    Time frame: within 10 minutes of the procedure

    The amount of time it takes for the device operator to identify the proximal humerus intraosseous (IO) insertion site using their assigned proximal humerus IO site identification method and insert the IO needle Timing starts from the time the participant begins to palpate the proximal humerus and stops when the IO needle is inserted.

Sponsors and collaborators

Lead sponsor

Vidacare Corporation

Industry

Registry information

Official study title

A Study Evaluating Insertion Site Identification Methods Used to Establish Intraosseous Vascular Access in the Proximal Humerus

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2012
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.