Vascular Access
Conditions
Keywords
Intraosseous Vascular Access, IO Access, IO Vascular Access, EZ-IO
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.
Detailed description
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.
Interventions
Intraosseous vascular access in the proximal humerus.
Sponsors
Vidacare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use Score | 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. |
| Level of Confidence Score | 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. |
| Proximal Humerus Intraosseous (IO) Insertion Site Placement Score | 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. |
| Time to Intraosseous (IO) Catheter Placement | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLarry J Miller, MD
Vidacare Corporation
Participant flow
Recruitment details
40 licensed/certified clinicians with no prior training on establishing intraosseous (IO) vascular access in the proximal humerus (PH) were recruited for participation as device operators to learn one PH IO site identification method and perform one unilateral proximal humerus IO site insertion procedure. 20 healthy adults were recruited to receive PH IO vascular access in each PH using a different PH IO site identification method for each.
Pre-assignment details
Healthy volunteers had a physical exam to confirm no excess tissue was overlaying the proximal humerus IO insertion site and adequate landmarks were visible. Clinicians were trained on and had to correctly demonstrate their assigned method for IO vascular access in the proximal humerus for approval to participate as a device operator.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 8 / 10 | 9 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
None listed