Intraosseous Vascular AccessNCT01866514
Proximal Humerus Site for Anesthesia
A study testing intraosseous vascular access in the proximal humerus and EZ-IO in people with Intraosseous Vascular Access, run by Vidacare Corporation at 1 site in United States.
Trial summary
This will be a prospective, non-controlled study using healthy adult volunteers as subjects receiving bilateral proximal humerus intraosseous (IO) vascular access to evaluate the insertion technique and IO infusion flow rates. 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
- What is being tested?
- intraosseous vascular access in the proximal humerus and EZ-IO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 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
- Age 21 years or older
- Have no amputation of the upper extremities
- Able to lay flat on 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 Study Evaluating Use of the Proximal Humerus Intraosseous Vascular Access Site for Anesthesia Patient Positioning
This will be a prospective, non-controlled study using healthy adult volunteers as subjects receiving bilateral proximal humerus intraosseous (IO) vascular access to evaluate the insertion technique and IO infusion flow rates.
Read the detailed description
When using IO access in the perioperative and OR settings, abduction of the arms to the shoulder level prevents use of the traditional proximal humerus insertion site due to the rotation of the humeral head under the acromion process. An alternate proximal humerus IO insertion technique has been developed to meet the needs of anesthesia patient positioning that uses a slightly more distal insertion site and a superior angle of insertion. However infusion flow rate in the proximal humerus using the anesthesia technique has not been measured. This study is needed to evaluate the anesthesia proximal humerus IO insertion technique to determine if the IO infusion flow rates remain unchanged by the alternate method.
- Conditions
- Intraosseous Vascular Access
- Being tested
- intraosseous vascular access in the proximal humerus, EZ-IO
- Keywords
- EZ-IO, IO, Intraosseous Vascular Access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraosseous vascular access in the proximal humerusDevice
Also called EZ-IO, Proximal Humerus intraosseous access, IO access, proximal humerus IO access
The arm receiving the Intraosseous (IO) needle is positioned with the arm abducted to shoulder level (in position required for surgery), with the arm rotated inward, into the optimal position, with the palms faced down. Deeply palpate the humerus until the junction of the humeral shaft and the humeral head, the surgical neck is identified; the insertion site is in the surgical neck. With the 45mm IO needle placed perpendicular to the plane of the skin, the IO needle is inserted into the surgical neck using a slightly superior angle of insertion and the needle is inserted to the hub. The stylet will be removed and a primed EZ-Connect will be attached to the catheter hub.
EZ-IODevice
| Study group | Role | What they receive |
|---|---|---|
| Proximal Humerus Intraosseous Vascular Access - Anesthesia Position | Experimental | Adult healthy volunteers receiving bilateral proximal humerus intraosseous vascular access while arm is positioned abducted from the body at shoulder level, bilaterally. This arm position is referred to as the "anesthesia position" Receives: Device: intraosseous vascular access in the proximal humerus; Device: EZ-IO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraosseous Infusion Flow Rate
the mean infusion flow rate reported in milliliters per hour (mL/hr) obtained at each tested infusion pressure.
Measured: Day 1, within 30 minutes of establishing proximal humerus intraosseous (IO) vascular access
Secondary outcomes (2)
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
Time Measured in Seconds for Fluid Delivery From the Proximal Humerus Intraosseous (IO) Site to the Heart
time measured in seconds for fluid delivery from the proximal humerus intraosseous site to the heart, using visualization of contrast injection under fluoroscopy.
Measured: Day 1 within 1 hour after establishing proximal humerus intraosseous vascular 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 completionJun 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT01866514
- Sponsor's protocol ID
- 2013-07
- Status last verified
- Jan 2026
- First submitted
- 28 May 2013
- Last updated
- 17 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Use of the Proximal Humerus Intraosseous Vascular Access Site for Anesthesia Patient Positioning
- ClinicalTrials.gov ID
- NCT01866514
- Acronym / sponsor ID
- 2013-07
- Conditions
- Intraosseous Vascular Access
- Keywords
- EZ-IO, IO, Intraosseous Vascular Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vidacare CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2013 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 May 2013 (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.
This will be a prospective, non-controlled study using healthy adult volunteers as subjects receiving bilateral proximal humerus intraosseous (IO) vascular access to evaluate the insertion technique and IO infusion flow rates.
Detailed description
When using IO access in the perioperative and OR settings, abduction of the arms to the shoulder level prevents use of the traditional proximal humerus insertion site due to the rotation of the humeral head under the acromion process. An alternate proximal humerus IO insertion technique has been developed to meet the needs of anesthesia patient positioning that uses a slightly more distal insertion site and a superior angle of insertion. However infusion flow rate in the proximal humerus using the anesthesia technique has not been measured. This study is needed to evaluate the anesthesia proximal humerus IO insertion technique to determine if the IO infusion flow rates remain unchanged by the alternate method.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proximal Humerus Intraosseous Vascular Access - Anesthesia Position | Experimental | Device: intraosseous vascular access in the proximal humerus, Device: EZ-IOAdult healthy volunteers receiving bilateral proximal humerus intraosseous vascular access while arm is positioned abducted from the body at shoulder level, bilaterally. This arm position is referred to as the "anesthesia position" |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 years or older
- Have no amputation of the upper extremities
- Able to lay flat on table for up to 2 hours
- Self-reported as healthy, as confirmed by the PI
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 access in the proximal humerusAlso: EZ-IO, Proximal Humerus intraosseous access, IO access, proximal humerus IO accessThe arm receiving the Intraosseous (IO) needle is positioned with the arm abducted to shoulder level (in position required for surgery), with the arm rotated inward, into the optimal position, with the palms faced down. Deeply palpate the humerus until the junction of the humeral shaft and the humeral head, the surgical neck is identified; the insertion site is in the surgical neck. With the 45mm IO needle placed perpendicular to the plane of the skin, the IO needle is inserted into the surgical neck using a slightly superior angle of insertion and the needle is inserted to the hub. The stylet will be removed and a primed EZ-Connect will be attached to the catheter hub. | Device | Proximal Humerus Intraosseous Vascular Access - Anesthesia Position |
| EZ-IO | Device | Proximal Humerus Intraosseous Vascular Access - Anesthesia Position |
Primary outcome
Intraosseous Infusion Flow Rate
Time frame: Day 1, within 30 minutes of establishing proximal humerus intraosseous (IO) vascular access
the mean infusion flow rate reported in milliliters per hour (mL/hr) obtained at each tested infusion pressure.
2 secondary outcomes
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
Time Measured in Seconds for Fluid Delivery From the Proximal Humerus Intraosseous (IO) Site to the Heart
Time frame: Day 1 within 1 hour after establishing proximal humerus intraosseous vascular access
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.
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 the proximal humerus and EZ-IO in people with Intraosseous 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 4 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 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?
Intraosseous Infusion Flow Rate (time frame: Day 1, within 30 minutes of establishing proximal humerus intraosseous (IO) vascular access). 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 17 Apr 2026.