Vascular AccessNCT01742780
Evaluation of Various Methods Used to Identify the Proximal Humerus Intraosseous Vascular Access Site
A study testing Intraosseous Vascular Access in people with Vascular Access, run by Vidacare Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Access
- What is being tested?
- Intraosseous Vascular Access
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2012
- 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
- 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.
- Age 21 years or older.
- Has no amputation of the upper extremities.
- Able to lay flat on table for up to 2 hours.
- Self-reported as healthy.
Who cannot join
- There is no exclusion criteria
- Have an active infection in the body
- Imprisoned
- Pregnant
- Cognitively impaired
- Fracture in humerus, or significant trauma to the site
Show all 10Show fewer
- Excessive tissue and/or absence of adequate anatomical landmarks in humerus
- Infection in target area
- Humeral intraosseous insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus
- Current use of anti-coagulants
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 Study Evaluating Insertion Site Identification Methods Used to Establish Intraosseous Vascular Access in the Proximal Humerus
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.
Read the 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.
- Conditions
- 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 AccessOther
Intraosseous vascular access in the proximal humerus.
| Study group | Role | What they receive |
|---|---|---|
| Vidacare Method for Intraosseous Insertion | Other | Clinicians with no prior training on identifying the proximal humerus IO insertion site to be trained on the Standard Vidacare Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Standard Vidacare Method description is: Palpate up the proximal humerus towards the anterior shoulder just above the surgical neck, to the greater tubercle of the proximal humerus. Insert the needle set perpendicular to skin with a slight downward angle at the most prominent aspect of greater tubercle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access. Receives: Other: Intraosseous Vascular Access |
| Saussy Method for Intraosseous Insertion | Other | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Saussy Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Saussy Method description is: Palpate the proximal humerus to locate the intertubercular groove; rotate the forearm medially and laterally to isolate the groove. Move one finger breadth laterally from the groove to the greater tubercle. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access Receives: Other: Intraosseous Vascular Access |
| Davlantes Method for Intraosseous Insertion | Other | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Davlantes Method site identification method and perform one unilateral proximal humerus IO needle insertion. The description of the Davlantes Method is: Using one hand, place the thumb on the acromioclavicular joint in the natural recess or "pocket" between the distal clavicle and the humeral head, wrapping the rest of the hand around the upper arm. The hand should be oriented such that the index finger and rest of the hand is at a 90-degree angle to the thumb. The webspace between the thumb and index finger will be approximately where the surgical neck of the humerus is; move one finger breadth (approximately 1 cm) superior. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access Receives: Other: Intraosseous Vascular Access |
| Campbell Method for Intraosseous Insertion | Other | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Campbell Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Campbell Method description is: With the fingers on both hands fully extended similar to a karate chop, place one hand into the anterior joint space (acromioclavicular joint) of the patient. Place the second "karate chop" hand along the midline of the patient's lateral shoulder; touch the pinkie fingers over the superior aspect of the patient's shoulder. Overlap the thumbs on the patient's shoulder, which will be at the most prominent aspect of the greater tubercle. Insert the needle set perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access Receives: Other: Intraosseous Vascular Access |
| Healthy Subjects: Campbell and Saussy Methods | Other | Healthy Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Saussy Method on one proximal humerus and the Campbell method on the other proximal humerus. Receives: Other: Intraosseous Vascular Access |
| Healthy Subject: Davlantes and Standard Vidacare Methods | Other | Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Davlantes Method on one proximal humerus and the Standard Vidacare method on the other proximal humerus. Receives: Other: Intraosseous Vascular Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Use Score
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.
Measured: Within 10 minutes of procedure
Level of Confidence Score
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.
Measured: within 10 minutes of procedure
Proximal Humerus Intraosseous (IO) Insertion Site Placement Score
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.
Measured: within 10 minutes of the procedure
Time to Intraosseous (IO) 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: within 10 minutes of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionDec 2012
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT01742780
- Sponsor's protocol ID
- 2012-16
- Status last verified
- Mar 2026
- First submitted
- 30 Nov 2012
- Last updated
- 17 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Reades R, Studnek JR, Vandeventer S, Garrett J. Intraosseous versus intravenous vascular access during out-of-hospital cardiac arrest: a randomized controlled trial. Ann Emerg Med. 2011 Dec;58(6):509-16. doi: 10.1016/j.annemergmed.2011.07.020.
PubMed 21856044Reades R, Studnek JR, Garrett JS, Vandeventer S, Blackwell T. Comparison of first-attempt success between tibial and humeral intraosseous insertions during out-of-hospital cardiac arrest. Prehosp Emerg Care. 2011 Apr-Jun;15(2):278-81. doi: 10.3109/10903127.2010.545479. Epub 2011 Jan 28.
PubMed 21275573Wampler D, Schwartz D, Shumaker J, Bolleter S, Beckett R, Manifold C. Paramedics successfully perform humeral EZ-IO intraosseous access in adult out-of-hospital cardiac arrest patients. Am J Emerg Med. 2012 Sep;30(7):1095-9. doi: 10.1016/j.ajem.2011.07.010. Epub 2011 Oct 24.
PubMed 22030185
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating Insertion Site Identification Methods Used to Establish Intraosseous Vascular Access in the Proximal Humerus
- ClinicalTrials.gov ID
- NCT01742780
- Acronym / sponsor ID
- 2012-16
- Conditions
- Vascular Access
- Keywords
- Intraosseous Vascular Access, IO Access, IO Vascular Access, EZ-IO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vidacare CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Posted 17 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Vidacare Method for Intraosseous Insertion | Other | Other: Intraosseous Vascular AccessClinicians with no prior training on identifying the proximal humerus IO insertion site to be trained on the Standard Vidacare Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Standard Vidacare Method description is: Palpate up the proximal humerus towards the anterior shoulder just above the surgical neck, to the greater tubercle of the proximal humerus. Insert the needle set perpendicular to skin with a slight downward angle at the most prominent aspect of greater tubercle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access. |
| Saussy Method for Intraosseous Insertion | Other | Other: Intraosseous Vascular AccessClinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Saussy Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Saussy Method description is: Palpate the proximal humerus to locate the intertubercular groove; rotate the forearm medially and laterally to isolate the groove. Move one finger breadth laterally from the groove to the greater tubercle. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| Davlantes Method for Intraosseous Insertion | Other | Other: Intraosseous Vascular AccessClinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Davlantes Method site identification method and perform one unilateral proximal humerus IO needle insertion. The description of the Davlantes Method is: Using one hand, place the thumb on the acromioclavicular joint in the natural recess or "pocket" between the distal clavicle and the humeral head, wrapping the rest of the hand around the upper arm. The hand should be oriented such that the index finger and rest of the hand is at a 90-degree angle to the thumb. The webspace between the thumb and index finger will be approximately where the surgical neck of the humerus is; move one finger breadth (approximately 1 cm) superior. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| Campbell Method for Intraosseous Insertion | Other | Other: Intraosseous Vascular AccessClinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Campbell Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Campbell Method description is: With the fingers on both hands fully extended similar to a karate chop, place one hand into the anterior joint space (acromioclavicular joint) of the patient. Place the second "karate chop" hand along the midline of the patient's lateral shoulder; touch the pinkie fingers over the superior aspect of the patient's shoulder. Overlap the thumbs on the patient's shoulder, which will be at the most prominent aspect of the greater tubercle. Insert the needle set perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| Healthy Subjects: Campbell and Saussy Methods | Other | Other: Intraosseous Vascular AccessHealthy Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Saussy Method on one proximal humerus and the Campbell method on the other proximal humerus. |
| Healthy Subject: Davlantes and Standard Vidacare Methods | Other | Other: Intraosseous Vascular AccessSubjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Davlantes Method on one proximal humerus and the Standard Vidacare method on the other proximal humerus. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Age 21 years or older.
- Has no amputation of the upper extremities.
Key exclusion criteria (10 listed)
- There is no exclusion criteria
- Have an active infection in the body
- Imprisoned
- Pregnant
- Cognitively impaired
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 AccessIntraosseous vascular access in the proximal humerus. | Other | Campbell Method for Intraosseous Insertion, Davlantes Method for Intraosseous Insertion, Healthy Subject: Davlantes and Standard Vidacare Methods, Healthy Subjects: Campbell and Saussy Methods, Saussy Method for Intraosseous Insertion, Vidacare Method for Intraosseous Insertion |
Primary outcome
Ease of Use Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21856044Reades R, Studnek JR, Vandeventer S, Garrett J. Intraosseous versus intravenous vascular access during out-of-hospital cardiac arrest: a randomized controlled trial. Ann Emerg Med. 2011 Dec;58(6):509-16. doi: 10.1016/j.annemergmed.2011.07.020.
- Background: PubMed 21275573Reades R, Studnek JR, Garrett JS, Vandeventer S, Blackwell T. Comparison of first-attempt success between tibial and humeral intraosseous insertions during out-of-hospital cardiac arrest. Prehosp Emerg Care. 2011 Apr-Jun;15(2):278-81. doi: 10.3109/10903127.2010.545479. Epub 2011 Jan 28.
- Background: PubMed 22030185Wampler D, Schwartz D, Shumaker J, Bolleter S, Beckett R, Manifold C. Paramedics successfully perform humeral EZ-IO intraosseous access in adult out-of-hospital cardiac arrest patients. Am J Emerg Med. 2012 Sep;30(7):1095-9. doi: 10.1016/j.ajem.2011.07.010. Epub 2011 Oct 24.
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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 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 10 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 17 Apr 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 17 Apr 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?
Ease of Use Score (time frame: Within 10 minutes of procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01742780, which also lists 3 linked publications.
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 17 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.