An interventional study of intraosseous vascular access in the proximal humerus and EZ-IO in Intraosseous Vascular Access, sponsored by Vidacare Corporation. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Vidacare Corporation · Not applicable, Interventional, and Other
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.
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.
Vidacare Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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"
Device: intraosseous vascular access in the proximal humerus · Device: EZ-IO
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.
Also known as: EZ-IO, Proximal Humerus intraosseous access, IO access, proximal humerus IO access
Intraosseous Infusion Flow Rate
the mean infusion flow rate reported in milliliters per hour (mL/hr) obtained at each tested infusion pressure.
Time frame: Day 1, within 30 minutes of establishing proximal humerus intraosseous (IO) vascular access
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.
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 measured in seconds for fluid delivery from the proximal humerus intraosseous site to the heart, using visualization of contrast injection under fluoroscopy.
Time frame: Day 1 within 1 hour after establishing proximal humerus intraosseous vascular access
| Milestone | Proximal Humerus Intraosseous Vascular Access - Anesthesia Position |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
the mean infusion flow rate reported in milliliters per hour (mL/hr) obtained at each tested infusion pressure.
| mL / hour | Anesthesia Arm |
|---|---|
| Intraosseous Infusion Flow Rate | 2433.33 ± 1234.23 |
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.
| Participants | Anesthesia Arm |
|---|---|
| Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens | 5 |
time measured in seconds for fluid delivery from the proximal humerus intraosseous site to the heart, using visualization of contrast injection under fluoroscopy.
| seconds | Anesthesia Arm |
|---|---|
| Time Measured in Seconds for Fluid Delivery From the Proximal Humerus Intraosseous (IO) Site to the Heart | 2.07 ± 0.28 |
Collected over 24 hours, from enrollment in the study on day 1 through 24 hours follow up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Proximal Humerus Intraosseous Vascular Access - Anesthesia Position | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Proximal Humerus Intraosseous Vascular Access - Anesthesia Position |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Proximal Humerus Intraosseous Vascular Access - Anesthesia Position |
|---|---|
| Female | 3 |
| Male | 2 |
| Race and Ethnicity Not Collected(Participants) | Proximal Humerus Intraosseous Vascular Access - Anesthesia Position |
|---|
| Region of Enrollment(Participants) | Proximal Humerus Intraosseous Vascular Access - Anesthesia Position |
|---|---|
| United States | 5 |
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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