Intraosseous Vascular AccessNCT01866501
Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site
A study testing Intraosseous Vascular Access in people with Intraosseous Vascular Access and Vascular Access, run by Vidacare Corporation at 1 site in United States.
Trial summary
A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraosseous Vascular Access, Vascular Access
- What is being tested?
- Intraosseous Vascular Access
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bulverde-Spring Branch EMS
Spring Branch, Texas, 78070
About this study
Official title: A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site
A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site
Read the 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.
- Conditions
- Intraosseous Vascular Access, Vascular Access
- Being tested
- Intraosseous Vascular Access
- Keywords
- Intraosseous Vascular Access, IO Access, IO Vascular Access, EZ-IO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous Vascular AccessDevice
Also called EZ-IO, Proximal Humerus IO Access, IO
Intraossesous Vascular Access in the proximal humerus
| Study group | Role | What they receive |
|---|---|---|
| Blended Technique for Intraosseous Insertion | Other | Clinician device operators will be trained on the Blended Technique site identification method and perform one unilateral proximal humerus (PH) intraosseous needle insertion. The blended technique is: The arm is positioned with the elbow adducted and shoulder internally rotated with the hand over the abdomen. The operator places one hand in the axilla and the other hand along the midline of the upper arm laterally, to define the anterior and posterior borders. The vertical plane of insertion lies in the middle of these borders. Along the vertical axis, deeply palpate the PH until the junction of the surgical neck and humeral head is identified. The insertion site is the greater tubercle, about 1-2 cm superior to the surgical neck. Secondary confirmation is made by palpating the inter-tubercular groove with a 90º rotation of the arm, confirming the insertion site is lateral to the groove, and returning the arm back to a medially rotated position with the hand over the abdomen Receives: Device: Intraosseous Vascular Access |
| Healthy Subjects: Blended Technique | Other | Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique. Receives: Device: Intraosseous Vascular Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score
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).
Measured: Day 1 Within 10 minutes following procedure
Time to Intraosseous Catheter Placement
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.
Measured: 1 day, within 10 minutes of procedure
Level of Confidence Score Pre-intraosseous Insertion
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.
Measured: Day 1 within 10 minutes of completing training
Level of Confidence Score Post-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.
Measured: Day 1 within 10 minutes of completing the unilateral intraosseous insertion
Ease of Use Score Pre-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.
Measured: Day 1 within 10 minutes of completing the unilateral intraosseous insertion
Ease of Use Score Post-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 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.
Measured: Day 1 within 10 minutes of completing the unilateral insertion
Secondary outcomes (3)
Intraosseous Infusion Flow Rates
Intraosseous infusion flow rates attained at tested infusion pressures, which may include Gravity; 100 mmHg, 200 mmHg and 300 mmHg.
Measured: Day 1 after establishing IO vascular access
Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart
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.
Measured: Day 1 after IO insertion
Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens
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
Measured: Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intraosseous Vascular AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidacare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry J Miller, MD, Principal investigator, Vidacare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866501
- Sponsor's protocol ID
- 2013-06
- Status last verified
- May 2013
- First submitted
- 28 May 2013
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site
- ClinicalTrials.gov ID
- NCT01866501
- Acronym / sponsor ID
- 2013-06
- Conditions
- Intraosseous Vascular Access, Vascular Access
- Keywords
- Intraosseous Vascular Access, IO Access, IO Vascular Access, EZ-IO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vidacare CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blended Technique for Intraosseous Insertion | Other | Device: Intraosseous Vascular AccessClinician device operators will be trained on the Blended Technique site identification method and perform one unilateral proximal humerus (PH) intraosseous needle insertion. The blended technique is: The arm is positioned with the elbow adducted and shoulder internally rotated with the hand over the abdomen. The operator places one hand in the axilla and the other hand along the midline of the upper arm laterally, to define the anterior and posterior borders. The vertical plane of insertion lies in the middle of these borders. Along the vertical axis, deeply palpate the PH until the junction of the surgical neck and humeral head is identified. The insertion site is the greater tubercle, about 1-2 cm superior to the surgical neck. Secondary confirmation is made by palpating the inter-tubercular groove with a 90º rotation of the arm, confirming the insertion site is lateral to the groove, and returning the arm back to a medially rotated position with the hand over the abdomen |
| Healthy Subjects: Blended Technique | Other | Device: Intraosseous Vascular AccessHealthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Age 21 years or older
- Have no amputation of the upper extremities
Key exclusion criteria (18 listed)
- Have an active infection in the body
- Imprisoned
- Pregnant
- Cognitively impaired
- Fracture in humerus, or significant trauma to the site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraosseous Vascular AccessAlso: EZ-IO, Proximal Humerus IO Access, IOIntraossesous Vascular Access in the proximal humerus | Device | Blended Technique for Intraosseous Insertion, Healthy Subjects: Blended Technique |
Primary outcome
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).
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.
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.
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.
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.
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.
3 secondary outcomes
Intraosseous Infusion Flow Rates
Time frame: Day 1 after establishing IO vascular access
Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart
Time frame: Day 1 after IO insertion
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry J Miller, MD principal investigator
Vidacare Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraosseous Vascular Access in people with Intraosseous Vascular Access and Vascular Access, run by Vidacare Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score (time frame: Day 1 Within 10 minutes following procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.