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Completed

NCT Number: NCT01866501

Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site

A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site

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Key information

Conditions

Intraosseous Vascular Access 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

In 2012, the investigators from Vidacare evaluated 4 techniques commonly used to identify the proximal humerus IO insertion site to determine if one technique resulted in more consistent successful placement of the IO needle set with a higher level of confidence among device operators performing the techniques. Results suggest that a combination of the best features of the 4 techniques may lead to optimal IO needle set placement more consistently. This study is needed to validate the "Blended" proximal humerus IO insertion technique to confirm that use of the technique results in proper site identification among device operators and results in increased confidence.To most closely evaluate the Blended proximal humerus insertion technique and how it is received by clinicians who perform these procedures in actual patients, device operators will include licensed/certified clinicians including, emergency medicine technicians/paramedics and nurses.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Device Operators:

  • Currently licensed/certified Emergency Medicine Technicians, paramedic, or nurse
  • Have had no formal training on use of the proximal humerus IO insertion site
  • Demonstrate proper use of the device and technique during training portion and obtain approval from the device trainer to participate

Exclusion criteria

for Device Operators: None

Inclusion criteria

Healthy Subjects:

  • Age 21 years or older
  • Have no amputation of the upper extremities
  • Able to lay flat on a table for up to 2 hours
  • Self-reported as healthy, as confirmed by the PI

Exclusion criteria

Health Subjects:

  • 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 IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus
  • Current use of anti-coagulants
  • Current cardiac condition requiring pacemaker or anti-arrhythmic drugs
  • Prior adverse reaction to lidocaine
  • Volunteers with any of the following characteristics may be excluded from the infusion pathway evaluation involving administration of contrast dye at the discretion of the PI:
  • Prior adverse reaction to contrast dye
  • Allergy to any food or drug
  • History of impaired renal function
  • History of impaired hepatic function
  • History of cardiac disease
  • History of pheochromocytoma

Treatment and study plan

Intraosseous Vascular Access

Device

Intraossesous Vascular Access in the proximal humerus

Other names: EZ-IO, Proximal Humerus IO Access, IO

Primary outcomes

  1. Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score

    Time frame: Day 1 Within 10 minutes following procedure

    X-ray images of the inserted IO needle will be used to evaluate placement success and scored. Each insertion is scored by a musculoskeletal radiologist for two measures: Insertion Site Accuracy (scale range 0 - 3) and Needle Tip Location (scale range -7 to 7) as described below.

    The Total score is the sum of Insertion Site Accuracy Score and Needle Tip Location Score. Scale range -7 to 10; higher score indicates greater accuracy.

    Insertion Site Accuracy Score Scale is 0 to 3 where higher scores indicate greater accuracy: 3=center of greater tubercle, 2=perimeter of greater tubercle, 1=junction of greater tubercle and shaft or head, and 0=outside the greater tubercle.

    Needle tip Location Score Scale ranges from -7 to 7 where higher scores indicate more favorable needle tip location: 7=within center of proximal humerus (PH), 5=within PH not centered, 3= Near miss of PH, -3=In humeral head, -3=on epiphyseal line, -5=lateral miss (of the humerus), -7=medial miss (of the humerus).

  2. Time to Intraosseous Catheter Placement

    Time frame: 1 day, within 10 minutes of 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.

  3. Level of Confidence Score Pre-intraosseous Insertion

    Time frame: Day 1 within 10 minutes of completing training

    Device operators scored their perceived Level of Confidence with their assigned Intraosseous (IO) Insertion method. The score was reported following the completion of training but before performing the unilateral IO insertion. The Level of Confidence scale scores range from 1 to 5, where. 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=very confident, and 5=extremely confident. Higher scores indicate greater level of confidence.

  4. Level of Confidence Score Post-intraosseous Insertion

    Time frame: Day 1 within 10 minutes of completing the unilateral intraosseous insertion

    Device operators scored their perceived Level of Confidence with their assigned Intraosseous (IO) Insertion method for their one unilateral proximal humerus IO site procedure. The score was reported after performing the unilateral IO insertion. The Level of Confidence scale scores range from 1 to 5, where. 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=very confident, and 5=extremely confident. Higher scores indicate greater level of confidence.

  5. Ease of Use Score Pre-intraosseous Insertion

    Time frame: Day 1 within 10 minutes of completing the unilateral intraosseous insertion

    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 score was reported following the completion of training but before performing the unilateral IO insertion. The Ease of Use scale scores range from 1 to 5, where 1=very difficult, 2=difficult, 3=neutral, 4=easy, and 5=very easy. Higher scores indicate greater ease of use.

  6. Ease of Use Score Post-intraosseous Insertion

    Time frame: Day 1 within 10 minutes of completing the unilateral insertion

    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 score was reported after completing the unilateral intraosseous insertion. The Ease of Use scale scores range from 1 to 5, where 1=very difficult, 2=difficult, 3=neutral, 4=easy, and 5=very easy. Higher scores indicate greater ease of use.

Secondary outcomes

  1. Intraosseous Infusion Flow Rates

    Time frame: Day 1 after establishing IO vascular access

    Intraosseous infusion flow rates attained at tested infusion pressures, which may include Gravity; 100 mmHg, 200 mmHg and 300 mmHg.

  2. Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart

    Time frame: Day 1 after IO insertion

    Time in seconds for fluid delivery from the proximal humerus to the heart, using visualization of contrast injection under fluoroscopy was performed and measured once for the participants in the Healthy Subjects: Blended Technique arm.

  3. Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens

    Time frame: Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access

    Number of Participants with Laboratory Results Successfully Obtained from both intraosseous (IO) and peripheral venous blood specimens. Success was determined if the point-of-care laboratory analysis system provided laboratory results values for both IO and Peripheral Venous specimens. It was deemed unsuccessful if the point-of-care system provided no laboratory results values and/or noted an error for at least one specimen. An intraosseous blood specimen and a peripheral venous blood specimen were collected from each subject

Sponsors and collaborators

Lead sponsor

Vidacare Corporation

Industry

Registry information

Official study title

A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 31, 2013
Registry last updated
May 14, 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.

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