Intraosseous Vascular Access, Vascular Access
Conditions
Keywords
Intraosseous Vascular Access, IO Access, IO Vascular Access, EZ-IO
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.
Interventions
Intraossesous Vascular Access in the proximal humerus
Sponsors
Vidacare Corporation
Study design
Allocation
NON_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: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use Score Pre-intraosseous Insertion | 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. |
| Level of Confidence Score Pre-intraosseous Insertion | 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. |
| Level of Confidence Score Post-intraosseous Insertion | 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. |
| Ease of Use Score Post-intraosseous Insertion | 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. |
| Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score | 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). |
| Time to Intraosseous Catheter Placement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraosseous Infusion Flow Rates | 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. |
| Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart | 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. |
| Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLarry J Miller, MD
Vidacare Corporation
Participant flow
Recruitment details
10 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. 5 healthy adults were recruited to receive bilateral PH IO vascular access using the PH IO site identification method.
Pre-assignment details
Healthy volunteers had a physical exam to confirm no excess tissue was overlaying the proximal humerus intraosseous (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 | 5 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 |
| other Total, other adverse events | 0 / 10 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 5 |
Outcome results
None listed