A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Successful IO insertion
Study Overview
Brief Summary
A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Outcomes
Primary Outcomes
Successful IO insertion
Time Frame: Day 1 after establishing proximal humerus IO vascular access
Successful IO needle insertion determined by x-ray images
Secondary Outcomes
- Intraosseous Infusion flow rates(Day 1 after establishing IO vascular access)
- Relationship between IO and peripheral venous blood(Day 1 after establishing IO vascular access and peripheral venous access)
- Time in seconds for fluid delivery from the proximal humerus to the heart, using visualization of contrast injection under fluoroscopy.(Day 1 after IO insertion)